Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Quality Assurance Engineer is responsible for quality oversight of the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Durham AveXis site. The position will provide experience and expertise to transition a novel gene therapy into a commercially approved product. This individual must have strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections. Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch. Responsibilities Quality and Compliance aspects of design working in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that AveXis' new facility is: Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing Capable of manufacturing AveXis products that are safe, effective and that meet all applied controls and specifications Capable of meeting intended design goals of output volume, turnaround time and operating and product costs Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters). Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget. Contribute to design of facility, utilities and process equipment from a Quality and Compliance perspective. Act as Quality approver on project deliverables, as defined in the project plan. Work with AveXis validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective. Author and/or approve Standard Operating Procedures in support of project activity and deliverables. Qualifications Minimum B.S. degree, preferably in engineering or equivalent. A minimum of 2-4 years of directly related experience in biopharmaceutical based GMP manufacturing operations. Experience with viral gene therapies, cell culture technologies and/or orphan disease indications is a plus. Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements. Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience participating in internal audits, identify findings, driving to resolution and providing closure report. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Approximately 10% travel required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-TM1
Jan 18, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Quality Assurance Engineer is responsible for quality oversight of the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Durham AveXis site. The position will provide experience and expertise to transition a novel gene therapy into a commercially approved product. This individual must have strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections. Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch. Responsibilities Quality and Compliance aspects of design working in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that AveXis' new facility is: Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing Capable of manufacturing AveXis products that are safe, effective and that meet all applied controls and specifications Capable of meeting intended design goals of output volume, turnaround time and operating and product costs Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters). Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget. Contribute to design of facility, utilities and process equipment from a Quality and Compliance perspective. Act as Quality approver on project deliverables, as defined in the project plan. Work with AveXis validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective. Author and/or approve Standard Operating Procedures in support of project activity and deliverables. Qualifications Minimum B.S. degree, preferably in engineering or equivalent. A minimum of 2-4 years of directly related experience in biopharmaceutical based GMP manufacturing operations. Experience with viral gene therapies, cell culture technologies and/or orphan disease indications is a plus. Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements. Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience participating in internal audits, identify findings, driving to resolution and providing closure report. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Approximately 10% travel required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-TM1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The BioProcess Engineer is responsible organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. Responsibilities Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Participate in information requests for FDA and internal audits of the manufacturing facilities. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Qualifications 2-4 years' experience in Biological Manufacturing environment. Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. Excellent oral and written communication skills. Preferred: 2-4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems, strong technical writing ability and proven ability to effectively lead and participate on teams. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Jan 17, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The BioProcess Engineer is responsible organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. Responsibilities Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Participate in information requests for FDA and internal audits of the manufacturing facilities. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Qualifications 2-4 years' experience in Biological Manufacturing environment. Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. Excellent oral and written communication skills. Preferred: 2-4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems, strong technical writing ability and proven ability to effectively lead and participate on teams. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Personal Lines Insurance CSR Dynamic, growing insurance agency needs an experienced Personal Lines Account Manager to service an existing book of business. Experience including; Superior Customer Service, account setup, internal underwriting, new business marketing, policy issuance, cross selling abilities, renewals and remarketing. Must have and maintain a valid Property & Casualty insurance license in Illinois and have prior experience working in personal lines at the independent agency level or with a direct writer. Experience with utilizing an Agency Management System such as; Applied or Epic is preferred. Must be able to work in a fast paced environment, abide by all state insurance laws, insurance carrier regulations and agency procedures. Must be able to develop and maintain strong professional relationships with clients. Essential Responsibilities: Coordinate designated new business and set up new accounts in the agency management system Service and maintain the designated book of business Process renewals in a timely fashion Responsible for High End customers and high value home and auto packages Negotiate with underwriters on acceptability, coverages, pricing and terms Secure coverage offers from carriers and review for accuracy Complete applications for new business and process renewals Quote, remarket, review and process personal policies Communicate with clients at policy renewal to review coverages Ability to understand the best fit for the related industry Experience with home, auto, motorcycle, watercraft, multiple homes, ATV and RV policies Follow and abide by all agency procedures and guidelines 2 (two) plus years of experience servicing personal insurance accounts Must possess and maintain a valid Property & Casualty Insurance license in the state of Illinois College Degree Preferred or equivalent experience will be considered Experience with an Agency Management System is preferred Proficient in servicing and processing new business in personal lines Strong negotiating and organizational skills Must be able to process business insurance proposals Superior Customer Service abilities Professional appearance, attitude and work ethic Background and Reference Check will be conducted Our company is an equal opportunity employer, offering competitive wages and benefits. The successful candidate will have an opportunity to join a growing insurance agency. If you consider yourself one of the best and brightest Personal Lines CSRs in the country, please forward your resume to Human Resources.
Jan 17, 2020
Full time
Personal Lines Insurance CSR Dynamic, growing insurance agency needs an experienced Personal Lines Account Manager to service an existing book of business. Experience including; Superior Customer Service, account setup, internal underwriting, new business marketing, policy issuance, cross selling abilities, renewals and remarketing. Must have and maintain a valid Property & Casualty insurance license in Illinois and have prior experience working in personal lines at the independent agency level or with a direct writer. Experience with utilizing an Agency Management System such as; Applied or Epic is preferred. Must be able to work in a fast paced environment, abide by all state insurance laws, insurance carrier regulations and agency procedures. Must be able to develop and maintain strong professional relationships with clients. Essential Responsibilities: Coordinate designated new business and set up new accounts in the agency management system Service and maintain the designated book of business Process renewals in a timely fashion Responsible for High End customers and high value home and auto packages Negotiate with underwriters on acceptability, coverages, pricing and terms Secure coverage offers from carriers and review for accuracy Complete applications for new business and process renewals Quote, remarket, review and process personal policies Communicate with clients at policy renewal to review coverages Ability to understand the best fit for the related industry Experience with home, auto, motorcycle, watercraft, multiple homes, ATV and RV policies Follow and abide by all agency procedures and guidelines 2 (two) plus years of experience servicing personal insurance accounts Must possess and maintain a valid Property & Casualty Insurance license in the state of Illinois College Degree Preferred or equivalent experience will be considered Experience with an Agency Management System is preferred Proficient in servicing and processing new business in personal lines Strong negotiating and organizational skills Must be able to process business insurance proposals Superior Customer Service abilities Professional appearance, attitude and work ethic Background and Reference Check will be conducted Our company is an equal opportunity employer, offering competitive wages and benefits. The successful candidate will have an opportunity to join a growing insurance agency. If you consider yourself one of the best and brightest Personal Lines CSRs in the country, please forward your resume to Human Resources.
AutoNation AutoNation Toyota Libertyville
Libertyville, IL, USA
AutoNation Toyota Libertyville At AutoNation, doing what's right by the customer comes standard at 300 locations coast to coast, so it's no wonder we have served over 10 million happy customers. As a Service Advisor, you'll be part of a nationwide team servicing 20,000 cars a day and building customer loyalty that spans generations. Along with your communication skills and automotive knowledge, you'll utilize leading-edge technology to uncover selling opportunities that keep drivers safe in their vehicles. We represent 36 brands in 16 states, so there's always opportunity to grow your career as a Service Advisor and beyond. Join AutoNation and accelerate as far and fast as your talent and our support can take you. Position Overview Working in our state of the art service departments, the Service Advisor acts as the go-between for Service Technicians and customers. In this position, you'll be able to get out from behind the desk and play an active role in the service lane. AutoNation will look to you to explain the Service Technician's recommendations to the customer in easy-to-understand language - and suggest up-sell opportunities to keep the customer's vehicle safe. What Will I Do Every Day? Set, confirm and prepare for appointments with customers so they can have a great service experience Meet or exceed targeted sales goals & the targeted customer satisfaction index Greet customers in a friendly manner when they arrive Determine vehicle needs based on customer information and a vehicle walk-around, inspections and test drives Use a consultative selling process to assist customers in planning for ongoing required maintenance of their vehicle Produce repair orders for customers, including cost and time estimates, with full transparency Communicate frequently with technicians and parts associates to ensure timely completion of work Follow up with customers on the status of their vehicle, based on how the customer wants to be informed Follow up with customers to ensure satisfaction Gain superior product knowledge to effectively help customers Provide an exceptional customer experience to drive loyalty What are the requirements for this job? High school diploma or equivalent Proven ability to provide an exceptional customer experience Ability to set and achieve targeted goals Prior sales experience preferred but not required Demonstrated communication, consultative, interpersonal and organizational skills The willingness to follow up with customers Experience and desire to work with technology Valid in-state driver's license and an acceptable, safe driving record Why should I come work for AutoNation? You want to work for a car dealer that has a strong moral compass and treats all of its associates with respect AutoNation is an equal opportunity employer and a drug-free workplace.
Jan 16, 2020
Full time
AutoNation Toyota Libertyville At AutoNation, doing what's right by the customer comes standard at 300 locations coast to coast, so it's no wonder we have served over 10 million happy customers. As a Service Advisor, you'll be part of a nationwide team servicing 20,000 cars a day and building customer loyalty that spans generations. Along with your communication skills and automotive knowledge, you'll utilize leading-edge technology to uncover selling opportunities that keep drivers safe in their vehicles. We represent 36 brands in 16 states, so there's always opportunity to grow your career as a Service Advisor and beyond. Join AutoNation and accelerate as far and fast as your talent and our support can take you. Position Overview Working in our state of the art service departments, the Service Advisor acts as the go-between for Service Technicians and customers. In this position, you'll be able to get out from behind the desk and play an active role in the service lane. AutoNation will look to you to explain the Service Technician's recommendations to the customer in easy-to-understand language - and suggest up-sell opportunities to keep the customer's vehicle safe. What Will I Do Every Day? Set, confirm and prepare for appointments with customers so they can have a great service experience Meet or exceed targeted sales goals & the targeted customer satisfaction index Greet customers in a friendly manner when they arrive Determine vehicle needs based on customer information and a vehicle walk-around, inspections and test drives Use a consultative selling process to assist customers in planning for ongoing required maintenance of their vehicle Produce repair orders for customers, including cost and time estimates, with full transparency Communicate frequently with technicians and parts associates to ensure timely completion of work Follow up with customers on the status of their vehicle, based on how the customer wants to be informed Follow up with customers to ensure satisfaction Gain superior product knowledge to effectively help customers Provide an exceptional customer experience to drive loyalty What are the requirements for this job? High school diploma or equivalent Proven ability to provide an exceptional customer experience Ability to set and achieve targeted goals Prior sales experience preferred but not required Demonstrated communication, consultative, interpersonal and organizational skills The willingness to follow up with customers Experience and desire to work with technology Valid in-state driver's license and an acceptable, safe driving record Why should I come work for AutoNation? You want to work for a car dealer that has a strong moral compass and treats all of its associates with respect AutoNation is an equal opportunity employer and a drug-free workplace.
Summary: The School of Rock Music Instructor teaches students from ACDC to Zappa. The Instructor creates a safe and cool environment for students to achieve their musical and creative potential and insures that each School of Rock student has an exceptional musical journey.In support of that goal, the Vocal Instructor is responsible for all music and education-related elements within the lessons. The Instructor creates a dynamic lesson experience to ensure their students are challenged and inspired. The Instructor embodies rock and roll in a positive way and is responsible for creating the most valuable student lesson experience possible.We are currently looking for vocal instructors, but we teach five core areas at School of Rock - keys, vocals, guitar, bass and drums. Many of our instructors have broader musical talent as well which we do our best to engage. Music Instruction Maximize the quality of music instruction including private lessons and shows Be sure the students are learning the fundamentals of music, not just songs Create and document thoughtful lesson plans Customer Connection Communicate regularly with parents on progress of students after lessons Interact with parents and students regularly by being visible and accessible in the school Pitch in during canceled lessons in the overall execution of the program Assist in rehearsals and basic maintenance in school Candidate Requirements: 4 + years' experience teaching and/or performing music professionally Knowledge of music theory and curriculum design Excellent ability to deal well with a wide range of customers and other people Strong organizational skills Very strong customer relations skills Resourceful and good problem-solver Works well under pressure Ideal candidate is a working musician who also has formal music school training Enthusiastic, flexible, patient, and positive demeanor Good judgment a must Passion for teaching The Music Instructor provides quality music instruction through private lessons and shows for School of Rock Libertyville. This role creates a safe and inspiring environment for students to achieve their musical and creative potential and insures that each School of Rock student has a positive, exceptional musical journey.
Jan 16, 2020
Full time
Summary: The School of Rock Music Instructor teaches students from ACDC to Zappa. The Instructor creates a safe and cool environment for students to achieve their musical and creative potential and insures that each School of Rock student has an exceptional musical journey.In support of that goal, the Vocal Instructor is responsible for all music and education-related elements within the lessons. The Instructor creates a dynamic lesson experience to ensure their students are challenged and inspired. The Instructor embodies rock and roll in a positive way and is responsible for creating the most valuable student lesson experience possible.We are currently looking for vocal instructors, but we teach five core areas at School of Rock - keys, vocals, guitar, bass and drums. Many of our instructors have broader musical talent as well which we do our best to engage. Music Instruction Maximize the quality of music instruction including private lessons and shows Be sure the students are learning the fundamentals of music, not just songs Create and document thoughtful lesson plans Customer Connection Communicate regularly with parents on progress of students after lessons Interact with parents and students regularly by being visible and accessible in the school Pitch in during canceled lessons in the overall execution of the program Assist in rehearsals and basic maintenance in school Candidate Requirements: 4 + years' experience teaching and/or performing music professionally Knowledge of music theory and curriculum design Excellent ability to deal well with a wide range of customers and other people Strong organizational skills Very strong customer relations skills Resourceful and good problem-solver Works well under pressure Ideal candidate is a working musician who also has formal music school training Enthusiastic, flexible, patient, and positive demeanor Good judgment a must Passion for teaching The Music Instructor provides quality music instruction through private lessons and shows for School of Rock Libertyville. This role creates a safe and inspiring environment for students to achieve their musical and creative potential and insures that each School of Rock student has a positive, exceptional musical journey.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior Automation Engineer provides technical leadership to the automation team at our gene therapy manufacturing facility. Responsibilities Lead the design, configuration, installation, and maintenance of automation software (SCADA) and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention. Maintains, troubleshoots and modifies the GMP and non-GMP control systems; Systems may include plant wide SCADA, BMS, 3 rd party local control systems, freezers, air handlers and chillers. Prepare scopes of work and manage automation contractors as required to complete required work on within project timelines. Develop project objectives working with user requirement and business plans. Finish Determine equipment or system specifications and most cost-effective technology to be implemented. Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information. Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools. Responsible for maintaining procedures to meet GMP requirements, CFR's and internal company policies. Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing. Drive operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Problem solve any technically related issues impacting production. Support 24x7 site-based operations after startup. Create and update procedures to drive operational efficiency and compliance. Implement and revise SOPs to conform with standards and policies. Deploy, maintain, and upgrade manufacturing applications. Perform investigations of non-conformances related to automation systems. Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations. Execute change controls to update and upgrade automation systems and equipment. Qualifications BS. degree in Engineering, Computer Science, or related technical field. 8 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish. Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV). Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7). Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian). Experience in system level validation testing. Proven experience applying S88 in an automated environment. Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation. Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc. Experience writing and executing change controls. Able to develop MS SQL queries. In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality driven processes and end products. Excellent oral and written communication skills. Experience managing 3 rd parties (both in-sourcing and outsourcing). Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere. Provide technical support on all manufacturing issues when driving towards issue resolution. 10 - 50% travel may be required. This position will be located out of our Libertyville IL office. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Jan 16, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior Automation Engineer provides technical leadership to the automation team at our gene therapy manufacturing facility. Responsibilities Lead the design, configuration, installation, and maintenance of automation software (SCADA) and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention. Maintains, troubleshoots and modifies the GMP and non-GMP control systems; Systems may include plant wide SCADA, BMS, 3 rd party local control systems, freezers, air handlers and chillers. Prepare scopes of work and manage automation contractors as required to complete required work on within project timelines. Develop project objectives working with user requirement and business plans. Finish Determine equipment or system specifications and most cost-effective technology to be implemented. Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information. Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools. Responsible for maintaining procedures to meet GMP requirements, CFR's and internal company policies. Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing. Drive operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Problem solve any technically related issues impacting production. Support 24x7 site-based operations after startup. Create and update procedures to drive operational efficiency and compliance. Implement and revise SOPs to conform with standards and policies. Deploy, maintain, and upgrade manufacturing applications. Perform investigations of non-conformances related to automation systems. Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations. Execute change controls to update and upgrade automation systems and equipment. Qualifications BS. degree in Engineering, Computer Science, or related technical field. 8 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish. Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV). Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7). Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian). Experience in system level validation testing. Proven experience applying S88 in an automated environment. Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation. Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc. Experience writing and executing change controls. Able to develop MS SQL queries. In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality driven processes and end products. Excellent oral and written communication skills. Experience managing 3 rd parties (both in-sourcing and outsourcing). Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere. Provide technical support on all manufacturing issues when driving towards issue resolution. 10 - 50% travel may be required. This position will be located out of our Libertyville IL office. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Ref ID: 01383045Classification: Data Entry ClerkCompensation: $14.00 to $15.00 hourlyNeed for Data Entry Clerk! OfficeTeam is searching for individuals who are detail-oriented and looking to thrive in a dynamic, fast-paced environment. Other Responsibilities:- Requesting information for documents that are deemed incomplete- Keeping record of tasks, files, and progress- Entering information into specific fields in databases- Checking completed work for errors or duplicate information before submitting the final projectDo you have quick and accurate typing skills and exquisite organization? Then we may have a position for you. If interested, please submit an application or email a Microsoft Word copy of your resume directly to [Click Here to Email Your Resum]- Ability to multitask effectively- Reliable, hardworking, ability to take initiative, and work well both independently and with a team- Willingness to ask questions when issues arise- Excellent oral and written communication skillsOfficeTeam is the world's leader in professional staffing for office support jobs, focusing exclusively on the temporary and temporary-to-full-time placement of professionals in the administrative field. We are faster at finding you work because of the depth of our client network. Specifically, our professional staffing managers connect with thousands of hiring managers in North America every week to find your office support job opportunities. We evaluate all of our OfficeTeam temporaries' skills and match them with the needs of top employers in their area.OfficeTeam is the world's leader in professional staffing for office support jobs, focusing exclusively on the temporary and temporary-to-full-time placement of professionals in the administrative field. We are faster at finding you work because of the depth of our client network. Specifically, our professional staffing managers connect with thousands of hiring managers in North America every week to find your office support job opportunities. We evaluate all of our OfficeTeam temporaries' skills and match them with the needs of top employers in their area. Apply for this job now or contact us today at for additional information. All applicants applying for U.S. job openings must be authorized to work in the United States. All applicants applying for Canadian job openings must be authorized to work in Canada. 2019 OfficeTeam. A Robert Half Company. An Equal Opportunity Employer M/F/Disability/Veterans. By clicking 'Apply Now' you are agreeing to Robert Half Terms of Use.
Jan 16, 2020
Full time
Ref ID: 01383045Classification: Data Entry ClerkCompensation: $14.00 to $15.00 hourlyNeed for Data Entry Clerk! OfficeTeam is searching for individuals who are detail-oriented and looking to thrive in a dynamic, fast-paced environment. Other Responsibilities:- Requesting information for documents that are deemed incomplete- Keeping record of tasks, files, and progress- Entering information into specific fields in databases- Checking completed work for errors or duplicate information before submitting the final projectDo you have quick and accurate typing skills and exquisite organization? Then we may have a position for you. If interested, please submit an application or email a Microsoft Word copy of your resume directly to [Click Here to Email Your Resum]- Ability to multitask effectively- Reliable, hardworking, ability to take initiative, and work well both independently and with a team- Willingness to ask questions when issues arise- Excellent oral and written communication skillsOfficeTeam is the world's leader in professional staffing for office support jobs, focusing exclusively on the temporary and temporary-to-full-time placement of professionals in the administrative field. We are faster at finding you work because of the depth of our client network. Specifically, our professional staffing managers connect with thousands of hiring managers in North America every week to find your office support job opportunities. We evaluate all of our OfficeTeam temporaries' skills and match them with the needs of top employers in their area.OfficeTeam is the world's leader in professional staffing for office support jobs, focusing exclusively on the temporary and temporary-to-full-time placement of professionals in the administrative field. We are faster at finding you work because of the depth of our client network. Specifically, our professional staffing managers connect with thousands of hiring managers in North America every week to find your office support job opportunities. We evaluate all of our OfficeTeam temporaries' skills and match them with the needs of top employers in their area. Apply for this job now or contact us today at for additional information. All applicants applying for U.S. job openings must be authorized to work in the United States. All applicants applying for Canadian job openings must be authorized to work in Canada. 2019 OfficeTeam. A Robert Half Company. An Equal Opportunity Employer M/F/Disability/Veterans. By clicking 'Apply Now' you are agreeing to Robert Half Terms of Use.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Summer Intern will assist the Supply Chain Team in one of three areas: Finished drug product distribution Strategic Sourcing Site Purchasing Responsibilities Site Purchasing Track raw materials from time of purchase to time of receipt. Work within the Item Master and update via instruction from the Site Buyer/Planner. Assist Warehouse team with any incoming receipt issues. Participate in weekly meetings with key suppliers Strategic Sourcing Participate in the critical materials meetings and follow up with sites on action items Support the sourcing team on any ongoing sourcing projects possibly performing data analysis, interacting with suppliers Provide project support as needed Distribution Support the distribution team as needed to get drug product to sites of care for clinical studies and commercial doses. Support packaging/shipping validation studies for distribution Support order logistics and customs documents/requirements Qualifications Enrolled in a 4 year program in biochemistry, chemical engineering, bioengineering, finance or business. Excellent oral and written communication skills. 3.0 GPA. Must be able to routinely lift over 35 lbs. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Jan 16, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Summer Intern will assist the Supply Chain Team in one of three areas: Finished drug product distribution Strategic Sourcing Site Purchasing Responsibilities Site Purchasing Track raw materials from time of purchase to time of receipt. Work within the Item Master and update via instruction from the Site Buyer/Planner. Assist Warehouse team with any incoming receipt issues. Participate in weekly meetings with key suppliers Strategic Sourcing Participate in the critical materials meetings and follow up with sites on action items Support the sourcing team on any ongoing sourcing projects possibly performing data analysis, interacting with suppliers Provide project support as needed Distribution Support the distribution team as needed to get drug product to sites of care for clinical studies and commercial doses. Support packaging/shipping validation studies for distribution Support order logistics and customs documents/requirements Qualifications Enrolled in a 4 year program in biochemistry, chemical engineering, bioengineering, finance or business. Excellent oral and written communication skills. 3.0 GPA. Must be able to routinely lift over 35 lbs. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Overview Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Maintenance and Reliability Technician to perform all maintenance functions on production and facilities equipment for our Manufacturing facility. Responsibilities include routine inspection and repair or replacement of defective or faulty parts on machines and related equipment. All work to be performed ensuring good workmanship with minimum delay. Responsibilities Support the safe and effective operation of the plant and the facility. Perform preventive and predictive maintenance on production equipment and utility systems. Scope, plan, and execute repairs to and installation of plant machinery. Coordinate with site departments daily appropriate course of action to maximize uptime and quality performance of respective area. Operate machinery for purposes of training, troubleshooting, or as needed to support production activities. Initiate and participate in documented troubleshooting studies on equipment to outline opportunities for improvements. Document clear problem description, symptom, root cause and solution. Proven reasoning, troubleshooting and analytical thinking skills. Use shop equipment to repair or modify parts and equipment. Knowledge of, perform preventive maintenance, troubleshoot, and repair: AC and DC Motors & Drives Breakers and Fuses Pressure and Flow Controls Pressure Transducers/Switches Hydraulic and Pneumatic Systems Cylinders Filtration Systems Dampers Valves Pumps Drive Systems Piping Systems Pumps Fans Compressors Fire Protection Systems Qualifications Proficient in using personal computers and a working knowledge of software such as MS Excel and Word. Ability to analyze, investigate and help solve equipment technical issues. Good communication skills, both verbal and written. Must be flexible to work nights, weekends, and holidays as required. Ability to work with very minimum supervision. Must be proactive. Must have a good attitude regarding safety and lock out procedures. Technical school education in the areas of Manufacturing Engineer, Mechanical Engineering Technology, Electrical Engineering Technology or 6+ years equivalent education/experience. Proven experience in machine maintenance and troubleshooting skills. Good understanding of GMPs with experience in pharmaceutical environment. Read and understand mechanical and assembly drawings, hydraulic/pneumatic, and electrical schematics. Read and understand P&ID (Piping & Instrumentation Diagram). Occasionally lift and/or move up to 50 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Jan 16, 2020
Full time
Overview Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Maintenance and Reliability Technician to perform all maintenance functions on production and facilities equipment for our Manufacturing facility. Responsibilities include routine inspection and repair or replacement of defective or faulty parts on machines and related equipment. All work to be performed ensuring good workmanship with minimum delay. Responsibilities Support the safe and effective operation of the plant and the facility. Perform preventive and predictive maintenance on production equipment and utility systems. Scope, plan, and execute repairs to and installation of plant machinery. Coordinate with site departments daily appropriate course of action to maximize uptime and quality performance of respective area. Operate machinery for purposes of training, troubleshooting, or as needed to support production activities. Initiate and participate in documented troubleshooting studies on equipment to outline opportunities for improvements. Document clear problem description, symptom, root cause and solution. Proven reasoning, troubleshooting and analytical thinking skills. Use shop equipment to repair or modify parts and equipment. Knowledge of, perform preventive maintenance, troubleshoot, and repair: AC and DC Motors & Drives Breakers and Fuses Pressure and Flow Controls Pressure Transducers/Switches Hydraulic and Pneumatic Systems Cylinders Filtration Systems Dampers Valves Pumps Drive Systems Piping Systems Pumps Fans Compressors Fire Protection Systems Qualifications Proficient in using personal computers and a working knowledge of software such as MS Excel and Word. Ability to analyze, investigate and help solve equipment technical issues. Good communication skills, both verbal and written. Must be flexible to work nights, weekends, and holidays as required. Ability to work with very minimum supervision. Must be proactive. Must have a good attitude regarding safety and lock out procedures. Technical school education in the areas of Manufacturing Engineer, Mechanical Engineering Technology, Electrical Engineering Technology or 6+ years equivalent education/experience. Proven experience in machine maintenance and troubleshooting skills. Good understanding of GMPs with experience in pharmaceutical environment. Read and understand mechanical and assembly drawings, hydraulic/pneumatic, and electrical schematics. Read and understand P&ID (Piping & Instrumentation Diagram). Occasionally lift and/or move up to 50 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsible for defining and leading development and improvement activities for the manufacturing processes used to manufacture AveXis gene therapy products. This individual will also be responsible for the interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements. Responsibilities Serving as a scientific and technical lead for process-related issues and investigations at the site. Lead and mentor staff. May formally manage a team including writing performance reviews and annual goals, holding one-on-ones, and handling HR related matters. Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Defining potential process improvements in conjunction with the global process owners and operations and leading the implementation of process changes. Participating in start-up efforts of new equipment, software or processes in manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Providing technical/scientific support on project deliverables such as remediation initiatives, plan reports, etc. Utilizing small-scale production processes and scaled-down lab processes to enable process troubleshooting, with the potential to oversee these experiments at external partners. Provide leadership for tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Identify opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Completion of requisite training and applicable policies and procedures related to the job function. Qualifications PhD in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 8 years of experience in support of biopharmaceutical manufacturing OR M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 10 years of experience in support of biopharmaceutical manufacturing OR B.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing. Excellent oral and written communication skills. 12+ years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish preferred. Familiar with global regulations on cGMP manufacturing of drug substance, drug product devices, validation/qualification requirements preferred. Strong technical writing ability. Proven ability to effectively lead and participate on teams preferred. Leadership experience of technical staff either directly or in a matrix organization preferred. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Jan 14, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsible for defining and leading development and improvement activities for the manufacturing processes used to manufacture AveXis gene therapy products. This individual will also be responsible for the interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements. Responsibilities Serving as a scientific and technical lead for process-related issues and investigations at the site. Lead and mentor staff. May formally manage a team including writing performance reviews and annual goals, holding one-on-ones, and handling HR related matters. Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Defining potential process improvements in conjunction with the global process owners and operations and leading the implementation of process changes. Participating in start-up efforts of new equipment, software or processes in manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Providing technical/scientific support on project deliverables such as remediation initiatives, plan reports, etc. Utilizing small-scale production processes and scaled-down lab processes to enable process troubleshooting, with the potential to oversee these experiments at external partners. Provide leadership for tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Identify opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Completion of requisite training and applicable policies and procedures related to the job function. Qualifications PhD in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 8 years of experience in support of biopharmaceutical manufacturing OR M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 10 years of experience in support of biopharmaceutical manufacturing OR B.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing. Excellent oral and written communication skills. 12+ years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish preferred. Familiar with global regulations on cGMP manufacturing of drug substance, drug product devices, validation/qualification requirements preferred. Strong technical writing ability. Proven ability to effectively lead and participate on teams preferred. Leadership experience of technical staff either directly or in a matrix organization preferred. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Manager of Building & Site Services is responsible for the effective functioning of the manufacturing, warehouse and office buildings including the cGMP facility, cGMP warehouse and four office locations. This position will provide an efficient and safe working environment for employees and their activities by using best business practices to manage resources, services, and processes to meet the needs of the company. Responsibilities Develop and implement a facility management program including preventative maintenance and life-cycle requirements. Management and development of pest control program. Conduct and document regular facilities inspections. Ensure compliance of the site with international regulatory agencies (including FDA and OSHA) in relation to facilities and maintenance operations, health and safety standards and industry codes. Allocate and manage facility space for maximum efficiency. Coordinate intra-office moves. Supervise maintenance and repair of architectural aspects of the facilities through small projects. Oversee facility refurbishment and renovations. Plan and manage facility central services such as pest control, reception, security, cleaning, and architectural repairs. Implement best practice processes to increase efficiency. Drive consistency across sites for similar services. Obtain quotes from vendors and suppliers. Calculate and compare costs for goods and services to maximize cost-effectiveness. Negotiate contracts to optimize delivery and cost savings. Coordinate and monitor activities of contract suppliers. Manage contractor and vendor relationships. Manage and review service contracts to ensure facility management needs are being met. Ensure delivery schedules, quantity and quality criteria are met. Check completed work by contractors and vendors. Verify payment and invoicing match contract pricing. Manage, develop and train contract staff. Prepare and track the facility budget. Monitor expenses and payments. Generate and present regular reports and reviews of facility-related budgets, finances, contracts, expenditures and purchases. Develop and implement cost reduction initiatives. Provide prompt response to requests and issues from facility occupants. Ensure corporate sustainability goals in facility operation. Track and excel in KPIs for facility services. Conduct customer service surveys and improve customer satisfaction levels. Coordinate with the landlord's facility management firm for space comfort, fire protection and safety issues and incident investigations for leased space. Qualifications Bachelor's degree in Mechanical, Electrical, Chemical or Facilities Engineering Minimum 10 years of experience in facilities management, process engineering, project management, business management, or construction management or a combination of these for the same minimum period. Proven ability to work in a cross functional team environment, with excellent communication and organizational skills at all levels including C-suite executives. Working knowledge of principles and practices of project management, business administration, procurement, contracts, financial principles and practices. Sound knowledge of health, safety and environmental regulations. Experience in construction, maintenance, and all facets of facility operations. Strong cGMP and regulatory knowledge. Strong knowledge of architectural finishes and components. Planning, problem analysis, and decision-making skills. Proficient computer skills utilizing MS Office suite applications, MS Project, Building Management Systems, Corporate ERP systems and Computerized Maintenance Management Systems (CMMS). Working in a team environment with excellent communication and organizational skills. Customer service focused. Ability to climb ladders and lift up to 50 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Jan 13, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Manager of Building & Site Services is responsible for the effective functioning of the manufacturing, warehouse and office buildings including the cGMP facility, cGMP warehouse and four office locations. This position will provide an efficient and safe working environment for employees and their activities by using best business practices to manage resources, services, and processes to meet the needs of the company. Responsibilities Develop and implement a facility management program including preventative maintenance and life-cycle requirements. Management and development of pest control program. Conduct and document regular facilities inspections. Ensure compliance of the site with international regulatory agencies (including FDA and OSHA) in relation to facilities and maintenance operations, health and safety standards and industry codes. Allocate and manage facility space for maximum efficiency. Coordinate intra-office moves. Supervise maintenance and repair of architectural aspects of the facilities through small projects. Oversee facility refurbishment and renovations. Plan and manage facility central services such as pest control, reception, security, cleaning, and architectural repairs. Implement best practice processes to increase efficiency. Drive consistency across sites for similar services. Obtain quotes from vendors and suppliers. Calculate and compare costs for goods and services to maximize cost-effectiveness. Negotiate contracts to optimize delivery and cost savings. Coordinate and monitor activities of contract suppliers. Manage contractor and vendor relationships. Manage and review service contracts to ensure facility management needs are being met. Ensure delivery schedules, quantity and quality criteria are met. Check completed work by contractors and vendors. Verify payment and invoicing match contract pricing. Manage, develop and train contract staff. Prepare and track the facility budget. Monitor expenses and payments. Generate and present regular reports and reviews of facility-related budgets, finances, contracts, expenditures and purchases. Develop and implement cost reduction initiatives. Provide prompt response to requests and issues from facility occupants. Ensure corporate sustainability goals in facility operation. Track and excel in KPIs for facility services. Conduct customer service surveys and improve customer satisfaction levels. Coordinate with the landlord's facility management firm for space comfort, fire protection and safety issues and incident investigations for leased space. Qualifications Bachelor's degree in Mechanical, Electrical, Chemical or Facilities Engineering Minimum 10 years of experience in facilities management, process engineering, project management, business management, or construction management or a combination of these for the same minimum period. Proven ability to work in a cross functional team environment, with excellent communication and organizational skills at all levels including C-suite executives. Working knowledge of principles and practices of project management, business administration, procurement, contracts, financial principles and practices. Sound knowledge of health, safety and environmental regulations. Experience in construction, maintenance, and all facets of facility operations. Strong cGMP and regulatory knowledge. Strong knowledge of architectural finishes and components. Planning, problem analysis, and decision-making skills. Proficient computer skills utilizing MS Office suite applications, MS Project, Building Management Systems, Corporate ERP systems and Computerized Maintenance Management Systems (CMMS). Working in a team environment with excellent communication and organizational skills. Customer service focused. Ability to climb ladders and lift up to 50 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsible for overseeing the quality function for the site including the development, implementation, maintenance and overall operation of quality assurance systems and activities and quality control systems. As a member of the Quality leadership team, the Senior Director will represent the site on projects, providing strategic input and recommendations. Responsibilities Develop and lead an effective, efficient Quality team (both Quality Assurance and Quality Control) at an AveXis operating site. Fully responsible for all aspects of Quality Assurance and Quality Control for the site. Fully responsible for key Quality decisions, including Batch Disposition (i.e. Batch release), deviations, change control and complaint investigations. Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes. Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Make recommendations for corrective actions necessary to ensure conformity with quality specifications. Create and lead a monthly Quality Management Review meeting (QMR) attended by senior leadership to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Develop strong cooperative working relationships with other site functions (e.g. Manufacturing, MS&T). Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Responsible for hiring and training a high-performing quality team to ensure robust quality systems are implemented and sustained, finished products conform to government and company standards and satisfy good manufacturing practices regulations. Participate in external vendor quality audit program. Manage findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product. Participate in the development and enforcement of Microbiology laboratory procedures and policies. Participate in the QC Microbiology laboratory strategy and provide oversight of operations. Manage site inspection preparation, management and response process. Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed). Provide quality input during manufacturing runs at CMOs. Ensure all stability studies are designed and executed to enable IND and BLA filings. Successfully design and approve material compatibility experiments of finished goods components. Develop budgets and monitor expenditures. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 12-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product and laboratory operations. Experience with viral gene therapies and/or orphan disease indications is a plus. 5-8 years of direct management experience of Quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience leading both internal and external vendor audits, identify findings, drive resolution and provide closure report. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability as a strategic thinker. Strong project management skills and ability to perform long-term project planning, team building, budgeting and operational Six sigma training or practical experience a plus. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #L1-GK1
Jan 13, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsible for overseeing the quality function for the site including the development, implementation, maintenance and overall operation of quality assurance systems and activities and quality control systems. As a member of the Quality leadership team, the Senior Director will represent the site on projects, providing strategic input and recommendations. Responsibilities Develop and lead an effective, efficient Quality team (both Quality Assurance and Quality Control) at an AveXis operating site. Fully responsible for all aspects of Quality Assurance and Quality Control for the site. Fully responsible for key Quality decisions, including Batch Disposition (i.e. Batch release), deviations, change control and complaint investigations. Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes. Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Make recommendations for corrective actions necessary to ensure conformity with quality specifications. Create and lead a monthly Quality Management Review meeting (QMR) attended by senior leadership to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Develop strong cooperative working relationships with other site functions (e.g. Manufacturing, MS&T). Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Responsible for hiring and training a high-performing quality team to ensure robust quality systems are implemented and sustained, finished products conform to government and company standards and satisfy good manufacturing practices regulations. Participate in external vendor quality audit program. Manage findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product. Participate in the development and enforcement of Microbiology laboratory procedures and policies. Participate in the QC Microbiology laboratory strategy and provide oversight of operations. Manage site inspection preparation, management and response process. Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed). Provide quality input during manufacturing runs at CMOs. Ensure all stability studies are designed and executed to enable IND and BLA filings. Successfully design and approve material compatibility experiments of finished goods components. Develop budgets and monitor expenditures. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 12-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product and laboratory operations. Experience with viral gene therapies and/or orphan disease indications is a plus. 5-8 years of direct management experience of Quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience leading both internal and external vendor audits, identify findings, drive resolution and provide closure report. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability as a strategic thinker. Strong project management skills and ability to perform long-term project planning, team building, budgeting and operational Six sigma training or practical experience a plus. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #L1-GK1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsible for overseeing the quality function for the site including the development, implementation, maintenance and overall operation of quality assurance systems and activities and quality control systems. As a member of the Quality leadership team, the Senior Director will represent the site on projects, providing strategic input and recommendations. Responsibilities Develop and lead an effective, efficient Quality team (both Quality Assurance and Quality Control) at an AveXis operating site. Fully responsible for all aspects of Quality Assurance and Quality Control for the site. Fully responsible for key Quality decisions, including Batch Disposition (i.e. Batch release), deviations, change control and complaint investigations. Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes. Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Make recommendations for corrective actions necessary to ensure conformity with quality specifications. Create and lead a monthly Quality Management Review meeting (QMR) attended by senior leadership to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Develop strong cooperative working relationships with other site functions (e.g. Manufacturing, MS&T). Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Responsible for hiring and training a high-performing quality team to ensure robust quality systems are implemented and sustained, finished products conform to government and company standards and satisfy good manufacturing practices regulations. Participate in external vendor quality audit program. Manage findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product. Participate in the development and enforcement of Microbiology laboratory procedures and policies. Participate in the QC Microbiology laboratory strategy and provide oversight of operations. Manage site inspection preparation, management and response process. Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed). Provide quality input during manufacturing runs at CMOs. Ensure all stability studies are designed and executed to enable IND and BLA filings. Successfully design and approve material compatibility experiments of finished goods components. Develop budgets and monitor expenditures. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 12-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product and laboratory operations. Experience with viral gene therapies and/or orphan disease indications is a plus. 5-8 years of direct management experience of Quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience leading both internal and external vendor audits, identify findings, drive resolution and provide closure report. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability as a strategic thinker. Strong project management skills and ability to perform long-term project planning, team building, budgeting and operational Six sigma training or practical experience a plus. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #L1-GK1
Jan 13, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsible for overseeing the quality function for the site including the development, implementation, maintenance and overall operation of quality assurance systems and activities and quality control systems. As a member of the Quality leadership team, the Senior Director will represent the site on projects, providing strategic input and recommendations. Responsibilities Develop and lead an effective, efficient Quality team (both Quality Assurance and Quality Control) at an AveXis operating site. Fully responsible for all aspects of Quality Assurance and Quality Control for the site. Fully responsible for key Quality decisions, including Batch Disposition (i.e. Batch release), deviations, change control and complaint investigations. Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes. Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Make recommendations for corrective actions necessary to ensure conformity with quality specifications. Create and lead a monthly Quality Management Review meeting (QMR) attended by senior leadership to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Develop strong cooperative working relationships with other site functions (e.g. Manufacturing, MS&T). Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Responsible for hiring and training a high-performing quality team to ensure robust quality systems are implemented and sustained, finished products conform to government and company standards and satisfy good manufacturing practices regulations. Participate in external vendor quality audit program. Manage findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product. Participate in the development and enforcement of Microbiology laboratory procedures and policies. Participate in the QC Microbiology laboratory strategy and provide oversight of operations. Manage site inspection preparation, management and response process. Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed). Provide quality input during manufacturing runs at CMOs. Ensure all stability studies are designed and executed to enable IND and BLA filings. Successfully design and approve material compatibility experiments of finished goods components. Develop budgets and monitor expenditures. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 12-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product and laboratory operations. Experience with viral gene therapies and/or orphan disease indications is a plus. 5-8 years of direct management experience of Quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience leading both internal and external vendor audits, identify findings, drive resolution and provide closure report. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability as a strategic thinker. Strong project management skills and ability to perform long-term project planning, team building, budgeting and operational Six sigma training or practical experience a plus. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #L1-GK1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Manufacturing Specialist is responsible to support the primary manufacturing process owner and the manufacturing group by providing required process input to the engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyville manufacturing sites. The Manufacturing Specialist will be the owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site. Responsibilities Support the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support). Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites. Serve as a manufacturing document owner for certain production process steps. Own critical manufacturing deviation investigations and define pragmatic and effective CAPAs. Identify, develop and implement process robustness improvements through lean principals. Lead process specific training for the direct manufacturing group. Support internal and external audits for manufacturing process steps. Support the PMO group for any technology transfer activities. Own manufacturing process related change controls. Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process. Responsible for providing manufacturing SME support on capital related projects. Qualifications Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations. Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations. In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Travel as required to other internal sites, vendors, and CMOs as required (~20%). The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Jan 10, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Manufacturing Specialist is responsible to support the primary manufacturing process owner and the manufacturing group by providing required process input to the engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyville manufacturing sites. The Manufacturing Specialist will be the owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site. Responsibilities Support the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support). Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites. Serve as a manufacturing document owner for certain production process steps. Own critical manufacturing deviation investigations and define pragmatic and effective CAPAs. Identify, develop and implement process robustness improvements through lean principals. Lead process specific training for the direct manufacturing group. Support internal and external audits for manufacturing process steps. Support the PMO group for any technology transfer activities. Own manufacturing process related change controls. Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process. Responsible for providing manufacturing SME support on capital related projects. Qualifications Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations. Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations. In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Travel as required to other internal sites, vendors, and CMOs as required (~20%). The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Vice President, Gene Therapy Partnerships will enable AveXis' goal of treating more patients with life-threatening neurological diseases by creating, building, and leading the new AveXis Gene Therapy Partnerships (GTP) group. The Gene Therapy field is growing rapidly and AveXis is in a unique position to create partnerships to foster growth of the AveXis business and the Gene Therapy Industry as a whole. The new AveXis GTP team will lead this effort and help to bring additional gene therapy products into the AveXis network and, consequently, patients worldwide. Responsibilities Identify the GTP team's personnel needs and recruit to build out a high performing, cross-functional team. Interface with potential gene therapy partners to showcase AveXis manufacturing capabilities. Participate in due diligence activities to assess technical and strategic fit of potential gene therapy partners. Work with AveXis business development and manufacturing strategy teams to develop execution plans for transfer of gene therapy assets. Lead tech transfer of gene therapy assets and work with partners to understand product requirements and constraints so that processes may be implemented at AveXis manufacturing sites. Monitor operational, financial, and quality performance of AveXis GTP group. Report metrics to AveXis leadership teams. Represent GTP as a member of the AveXis technical operations leadership team, reporting performance of GTP group and leading the discussion on forward looking GTP strategy. Qualifications Bachelor's degree in Engineering/Science, Business Administration or a related field. 15+ years operations/quality management experience in biotech/pharma industry with at least 5 years of senior leadership experience. Expertise in leading cross-functional teams and interfacing with multiple areas of the business. Experience working with contract suppliers and customers (ability to build strong relationships and influence positive results). Experience participating in assessment of technical and strategic fit of partners/organizations. Demonstrated ability to operate in a fast-paced, rapidly changing collaborative work environment. 20-40% travel. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Jan 10, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Vice President, Gene Therapy Partnerships will enable AveXis' goal of treating more patients with life-threatening neurological diseases by creating, building, and leading the new AveXis Gene Therapy Partnerships (GTP) group. The Gene Therapy field is growing rapidly and AveXis is in a unique position to create partnerships to foster growth of the AveXis business and the Gene Therapy Industry as a whole. The new AveXis GTP team will lead this effort and help to bring additional gene therapy products into the AveXis network and, consequently, patients worldwide. Responsibilities Identify the GTP team's personnel needs and recruit to build out a high performing, cross-functional team. Interface with potential gene therapy partners to showcase AveXis manufacturing capabilities. Participate in due diligence activities to assess technical and strategic fit of potential gene therapy partners. Work with AveXis business development and manufacturing strategy teams to develop execution plans for transfer of gene therapy assets. Lead tech transfer of gene therapy assets and work with partners to understand product requirements and constraints so that processes may be implemented at AveXis manufacturing sites. Monitor operational, financial, and quality performance of AveXis GTP group. Report metrics to AveXis leadership teams. Represent GTP as a member of the AveXis technical operations leadership team, reporting performance of GTP group and leading the discussion on forward looking GTP strategy. Qualifications Bachelor's degree in Engineering/Science, Business Administration or a related field. 15+ years operations/quality management experience in biotech/pharma industry with at least 5 years of senior leadership experience. Expertise in leading cross-functional teams and interfacing with multiple areas of the business. Experience working with contract suppliers and customers (ability to build strong relationships and influence positive results). Experience participating in assessment of technical and strategic fit of partners/organizations. Demonstrated ability to operate in a fast-paced, rapidly changing collaborative work environment. 20-40% travel. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The summer intern will work at the AveXis site on various activities including, but not limited to, equipment commissioning, product technology transfer, process validation preparation, data compilation and review, project execution, or investigation support. Responsibilities of primary importance are to ensure the successful completion of assignments to support GMP manufacturing. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation and project deliverables are complete and accurate, so issues can be addressed real time. Responsibilities Project based scope will include support for process technology transfer documentation and validation protocols. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is filled out correctly, training is current, and all Quality requirements are being followed. Maintain quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from development into GMP manufacturing. Qualifications Enrolled in a 4 year program or recently completed a bachelor's degree in engineering or life sciences. 3.00 GPA. Excellent oral and written communication skills. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Jan 10, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The summer intern will work at the AveXis site on various activities including, but not limited to, equipment commissioning, product technology transfer, process validation preparation, data compilation and review, project execution, or investigation support. Responsibilities of primary importance are to ensure the successful completion of assignments to support GMP manufacturing. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation and project deliverables are complete and accurate, so issues can be addressed real time. Responsibilities Project based scope will include support for process technology transfer documentation and validation protocols. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is filled out correctly, training is current, and all Quality requirements are being followed. Maintain quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from development into GMP manufacturing. Qualifications Enrolled in a 4 year program or recently completed a bachelor's degree in engineering or life sciences. 3.00 GPA. Excellent oral and written communication skills. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The BioProcess Engineer is responsible organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. Responsibilities Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Participate in information requests for FDA and internal audits of the manufacturing facilities. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Qualifications 2-4 years' experience in Biological Manufacturing environment. Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. Excellent oral and written communication skills. Preferred: 2-4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems, strong technical writing ability and proven ability to effectively lead and participate on teams. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Jan 10, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The BioProcess Engineer is responsible organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. Responsibilities Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Participate in information requests for FDA and internal audits of the manufacturing facilities. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Qualifications 2-4 years' experience in Biological Manufacturing environment. Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. Excellent oral and written communication skills. Preferred: 2-4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems, strong technical writing ability and proven ability to effectively lead and participate on teams. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The BioProcess Engineer I is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site during off hours. This individual will work on the manufacturing floor to produce product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, standardizing equipment and cleaning production area. Responsibilities Assist in manufacturing led investigations through partnerships with Quality and other business units at the site. Assist BPEs to determine root cause, implement a solution and a verification check to ensure the fix was effective. Assist with creation and on-going maintenance of all pertinent equipment, policies, and procedures. Be flexible in rotations between upstream and downstream to learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish. Assist in producing clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs. Support the product requirements to ensure that all products are produced according to plan. Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Partner with Quality to ensure a quality and compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Qualifications 0-2 years' experience in GMP environment with Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field or equivalent experience. Excellent oral and written communication skills. Entry level into the biopharmaceutical based GMP manufacturing operations, no experience necessary. Approximately 10% travel required. Must be able to routinely lift over 35 lbs. Must be able to work alternate 12 hour shifts and weekends, as needed. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Jan 10, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The BioProcess Engineer I is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site during off hours. This individual will work on the manufacturing floor to produce product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, standardizing equipment and cleaning production area. Responsibilities Assist in manufacturing led investigations through partnerships with Quality and other business units at the site. Assist BPEs to determine root cause, implement a solution and a verification check to ensure the fix was effective. Assist with creation and on-going maintenance of all pertinent equipment, policies, and procedures. Be flexible in rotations between upstream and downstream to learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish. Assist in producing clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs. Support the product requirements to ensure that all products are produced according to plan. Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Partner with Quality to ensure a quality and compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Qualifications 0-2 years' experience in GMP environment with Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field or equivalent experience. Excellent oral and written communication skills. Entry level into the biopharmaceutical based GMP manufacturing operations, no experience necessary. Approximately 10% travel required. Must be able to routinely lift over 35 lbs. Must be able to work alternate 12 hour shifts and weekends, as needed. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Manufacturing Specialist is responsible to support the primary manufacturing process owner and the manufacturing group by providing required process input to the engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyville manufacturing sites. The Manufacturing Specialist will be the owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site. Responsibilities Support the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support). Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites. Serve as a manufacturing document owner for certain production process steps. Own critical manufacturing deviation investigations and define pragmatic and effective CAPAs. Identify, develop and implement process robustness improvements through lean principals. Lead process specific training for the direct manufacturing group. Support internal and external audits for manufacturing process steps. Support the PMO group for any technology transfer activities. Own manufacturing process related change controls. Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process. Responsible for providing manufacturing SME support on capital related projects. Qualifications Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations. Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations. In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Travel as required to other internal sites, vendors, and CMOs as required (~20%). The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Jan 10, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Manufacturing Specialist is responsible to support the primary manufacturing process owner and the manufacturing group by providing required process input to the engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyville manufacturing sites. The Manufacturing Specialist will be the owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site. Responsibilities Support the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support). Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites. Serve as a manufacturing document owner for certain production process steps. Own critical manufacturing deviation investigations and define pragmatic and effective CAPAs. Identify, develop and implement process robustness improvements through lean principals. Lead process specific training for the direct manufacturing group. Support internal and external audits for manufacturing process steps. Support the PMO group for any technology transfer activities. Own manufacturing process related change controls. Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process. Responsible for providing manufacturing SME support on capital related projects. Qualifications Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations. Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations. In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Travel as required to other internal sites, vendors, and CMOs as required (~20%). The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Summer Intern will work at an AveXis site on various activities included, but not limited to, produce product, troubleshoot and/or validate equipment, help drive process improvements, help investigate deviations, provide market and other strategic analysis, and/or work with supply chain vendors. Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time. Responsibilities Project based scope could include manufacturing operations, documentation support, continuous improvement, and/or technology implementation. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Qualifications Enrolled in a 4 year program in biochemistry, chemical engineering, bioengineering or life sciences. Excellent oral and written communication skills. Experience in leading projects. Additional Requirements: Must be able to routinely lift over 35 lbs. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Jan 10, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Summer Intern will work at an AveXis site on various activities included, but not limited to, produce product, troubleshoot and/or validate equipment, help drive process improvements, help investigate deviations, provide market and other strategic analysis, and/or work with supply chain vendors. Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time. Responsibilities Project based scope could include manufacturing operations, documentation support, continuous improvement, and/or technology implementation. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Qualifications Enrolled in a 4 year program in biochemistry, chemical engineering, bioengineering or life sciences. Excellent oral and written communication skills. Experience in leading projects. Additional Requirements: Must be able to routinely lift over 35 lbs. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
