AveXis Inc.

AveXis Inc. Durham, NC, USA
Jul 19, 2019
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. AveXis is seeking an Engineer who is responsible for building out and supporting various data analytics systems. The successful candidate will work with Manufacturing Sciences and Technology (MSAT) as well as the Process Sciences teams to develop a strong foundation for data analytics for all sites within AveXis. Another key role will be to evaluate, select and implement software tools necessary to support the annual CPV report. As a member of the global team some travel may be required. This role will be responsible for the architecting and engineering as well as a leadership role in developing the overall strategy of the platform architecture. The successful candidate will work with the global data acquisition lead to find insight in the data and build real=time analytics and visualization tools to assist manufacturing operations. Responsibilities Leads the evaluation and implementation of modelling and simulation techniques and advanced statistical concepts for manufacturing projects Manages and maintains process monitoring tools Proactively engages with MS&T and other functions at the site and global level to identify ways to use statistics to improve how the organization manages data Ensure data scientists, data engineers, and analysts have the tools needed on the analytics platform Define and develop platform to fit the needs of Data and Analytics and support advanced analytics Provide expertise and knowledge in emerging technologies with strategic technology vendors Present technical findings to non-technical stakeholders at all levels of the organization to gain buy-in of both the concepts and the value of acting on design changes. Establish specifications in standard documentation - User Requirements (URS), Functional Specifications (FS) and Detail Design Specifications (DDS/HDS/SDS). Take programs from concept through execution while managing all stages in the process utilizing a strong set of project management tools. Responsible for maintaining relevant procedures to meet GAMP guidance, GxP requirements, CFR's, and internal company policies. Drive operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Perform/support investigations of non-conformances. 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 Qualifications Minimum B.S. degree in Engineering, Computer Science, or equivalent experience in related technical field. A minimum of 7 years of experience in manufacturing, including experience in a regulated (GMP) environment. Experience writing and executing change controls. Experience with tools such as Discoverant, Statistica, Seeq, Power BI, Simca Online Working knowledge of FDA regulations and guidance particularly 21 CFR part 11, GAMP5. Excellent oral and written communication skills. Experience managing third parties (both in-sourcing and outsourcing). Strong project management skill set with extensive experience in strategic / tactical planning and demonstrated ability to perform long-term project planning. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere. Experience providing technical support on manufacturing issues when driving towards issue resolution. Experience working as part of a multi-disciplinary team completing full project life-cycle implementations. Exposure to Industrial Control Systems including PLC, HMI/SCADA, PI historian, etc. 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-TT1
AveXis Inc. Durham, NC, USA
Jul 19, 2019
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. AveXis is seeking a Process Engineer - Drug Product. The primary focus of the position is the successful installation, startup, commissioning, and qualification of a new isolator and vial filler for the site. This position will provide opportunities to work on a challenging and rewarding project with diverse technologies and job responsibilities. Working in a small team environment, the successful candidate will lead projects with opportunities to exercise and further develop well-rounded skills in facility front-end engineering, process equipment design, and engineering project management. Responsibilities Act as subject matter expert (SME) and system owner for filling, labeling and packaging equipment. Lead the commissioning and qualification activities for new filling/packaging systems. Work closely with operations and Manufacturing sciences to evaluate new product introductions. Troubleshoot issues, determination of root cause, and development of effective corrective and preventative actions. Lead a robust equipment performance review and develop optimization strategies for peak equipment performance, including compliance, safety, and efficiency improvements. Provide imaginative, thorough and practicable solutions to a wide range of difficult problems. Accountable for all phases of the Change Control process for engineering owned changes. Participation in all regulatory inspections as equipment SME. Qualifications Bachelor's degree in Mechanical or Chemical Engineering, or related technical field or equivalent experience required. Minimum 5-8 years of experience with complex sterile filling systems and packaging operations, including qualification experience. Demonstrated ability to work and collaborate in cross functional teams in a fast pace, dynamic team setting. Working in a team environment, with excellent communication and organizational skills. Strong interpersonal, verbal and written communication skills are essential. 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-GK1
AveXis Inc. Durham, NC, USA
Jul 19, 2019
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 Engineer is responsible for assisting with the development and improvement of the drug product manufacturing processes used to manufacture AveXis gene therapy products at the site. This individual will support implementation of a new filling suite, as well as the collaboration with other departments on manufacturing related issues to drive resolution and process improvements. Responsibilities Serve as a scientific and technical representative for process-related issues and investigations at the facility. Partner with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards. Perform monitoring of critical quality attributes/critical process parameters against historical continued process verification data to maintain product quality and to control process drift. Implement potential process improvements in conjunction with operations. Participate in start-up efforts of new equipment, software or processes in manufacturing. Assist in documenting changes/updates to manufacturing processes and partner with manufacturing, engineering and validation to implement those changes. Provide technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports. Utilize small-scale production processes and scaled-down lab processes to enable process troubleshooting. 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 compliant manufacturing environment. Assist the technical operations team in resolving issues related to production. Qualifications Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field. 2-5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish. Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements. Strong technical writing ability. Proven ability to effectively participate on teams. Up to 25% travel may be 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-GK1
AveXis Inc. San Diego, CA, USA
Jul 19, 2019
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. AveXis is seeking a Senior Scientist, Assay Support who will play a crucial role in experimental design, execution and data interpretation of bioassays for sample testing and in the support of bioassay development and optimization. The candidate must have in-depth knowledge of cell biology and a track record of working in cell-based assay optimization, routine assay execution and management under GxP environment. The ability to quickly learn, meet tight timeline, manage two or more direct reports, efficiently communicate, multi-task with excellent organization skills is extremely important to successfully fulfill responsibilities. Responsibilities Lead and manage studies performed using established bioassays. Design experiments using proper standards and controls to support various studies such as process development, formulation study, lab investigation and troubleshooting. Plan assay execution and assign to direct reports. Explain the study and plan and ensure quality data are generated. Hands-on execution of assays is also expected. Interact with collaborators to discuss planning and to report data; help managers with assessing sample priorities and lab capacity. Interpret data, put together slide deck and present data in meetings to represent the team and Bioassay group. Troubleshoot and determine root cause of issues in assay performance. Support assay development/optimization and other proof of concept studies. Establish technology platforms (e.g. western blot, qPCR) and serve as SME for these platforms. Develop assays and build testing capacity as needed. Design/execute experiments as needed using various techniques to support proof of concept studies and ad-hoc experiments. Manage cell banking activities and other critical reagents programs. Help direct reports develop technically solid automation protocols. Lead/Contribute to GxP workflow within the Bioassay group. Lead or contribute to drafting of SOPs and other technical documents such as study protocols and reports. Establish control trending and monitor performance of various assays. Manage 2 or more direct reports by providing technical and scientific oversight and mentoring to help grow their career. Manage lab operation by overseeing lab instrument/inventory, ensuring lab safety and serving as the point of contact person for such matters (e.g. interaction with facility). Qualifications Bachelor's degree and must have minimum of 15 years of industry experience (10 years for Master's degree). Must have very strong cell culture techniques with good understanding of cell behavior and cell biology to be able to independently determine health and performance of cells that are used in critical assays. Extensive experience in optimizing, executing and managing bioassay performed in 96well plate setting such as imaging-based assays, ELISA and luminescence/fluorescent-based assay. Proven ability to design experiments using appropriate standards, controls and assay layout and to troubleshoot as needed. Broad experiences in cellular, biochemical and molecular biological methods including but not limited to immunostaining, flow cytometry, protein gel, Western blot, PCR and qPCR. Working knowledge in DOE and JMP software is a significant plus. Basic understanding of regulatory agency guidance such as FDA, ICH and EMA and hand-on experience is a plus. Enjoy learning and challenges. Especially, must be able to learn new instruments and master their software quickly. Ability to work in a fast-paced small but growing team environment and to prioritize work from multiple projects. Must be highly reliable and goals/deadlines oriented. Must have exceptional written and verbal communication skills to operate in an environment with many moving parts and diverse collaborators. Must possess excellent organization skills to be able to manage several projects in parallel. 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-EC1
AveXis Inc. Durham, NC, USA
Jul 19, 2019
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. AveXis is seeking a Process Engineer - Drug Product. The primary focus of the position is the successful installation, startup, commissioning, and qualification of a new isolator and vial filler for the site. This position will provide opportunities to work on a challenging and rewarding project with diverse technologies and job responsibilities. Working in a small team environment, the successful candidate will lead projects with opportunities to exercise and further develop well-rounded skills in facility front-end engineering, process equipment design, and engineering project management. Responsibilities Act as subject matter expert (SME) and system owner for filling, labeling and packaging equipment. Lead the commissioning and qualification activities for new filling/packaging systems. Work closely with operations and Manufacturing sciences to evaluate new product introductions. Troubleshoot issues, determination of root cause, and development of effective corrective and preventative actions. Lead a robust equipment performance review and develop optimization strategies for peak equipment performance, including compliance, safety, and efficiency improvements. Provide imaginative, thorough and practicable solutions to a wide range of difficult problems. Accountable for all phases of the Change Control process for engineering owned changes. Participation in all regulatory inspections as equipment SME. Qualifications Bachelor's degree in Mechanical or Chemical Engineering, or related technical field or equivalent experience required. Minimum 5-8 years of experience with complex sterile filling systems and packaging operations, including qualification experience. Demonstrated ability to work and collaborate in cross functional teams in a fast pace, dynamic team setting. Working in a team environment, with excellent communication and organizational skills. Strong interpersonal, verbal and written communication skills are essential. 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-GK1
AveXis Inc. Longmont, CO, USA
Jul 19, 2019
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. AveXis is seeking a highly motivated individual to join us as a Quality Control Microbiology Technician. This position will work with the Quality Control team in supporting our efforts in this exciting new area of gene therapy. This position will be responsible for environmental monitoring, product and raw material testing, and other general QC microbiology sampling and testing processes. Responsibilities Perform environmental and utilities monitoring in clean rooms and subsequent analyses. Perform bioburden, endotoxin, and cell culture assays. Perform general microbiology laboratory support assays, such as media qualification and organism identification. Perform general laboratory duties such as stocking and ordering supplies. Perform other duties as assigned. Qualifications Bachelor's degree in Microbiology or related discipline or Associate's degree with a preference for experience within a laboratory setting. Ability to gown for entry into Aseptic core and supporting areas and lift approximately 25 pounds. Proficient in Microsoft Word, Excel, Power Point and other applications. Ability to communicate and work in a team environment. Comfortable in a fast-paced small company environment with proven ability to adjust workload based upon changing priorities. Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Excellent interpersonal, verbal and written communication skills. Ability to work in a cleanroom environment. 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-RL1
AveXis Inc. Durham, NC, USA
Jul 19, 2019
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. The Director, Quality Assurance (QA) Operations is responsible for designing and implementing innovative and robust processes for Quality review and release activities associated with a viral gene therapy manufacturing site which includes bulk product and sterile fill operations. This person will be responsible for developing the strategy for overall site quality operations including but not limited to: on-the-floor QA review activities which support a multi-shift manufacturing schedule, collaborating with Manufacturing operations to authorize written procedures such as: pre and post approval of batch production records, raw material/component specifications, facility related SOPs, calibration/maintenance documentation, consumable and raw material release. In addition, this individual will oversee and manage overall batch release activities to support a multi-product, multi-phase manufacturing scope and will bring a phase appropriate approach to the execution of quality oversight. This position will lead product quality reviews for the site and act as the primary liaison for QP related release needs. Responsibilities Develop and deliver robust procedures and processes for efficient oversight and release of GMP consumables, disposables, raw materials, bulk drug product and finished vials. Act as a critical thought leader for site GMP operations and workflows. Create risk based, compliance and business aligned strategies for phase appropriate batch release operations. 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). Recruit and manage a high performing, collaborative team of QA operations professionals to support quality operation activities including: SOP/Document Management: Approve all instruction sets, specifications, sampling instructions, test methods etc. and other quality control procedures directly related to operations and other cGMP activities. In collaboration with the Quality Systems team, ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause. Component/Disposable/Raw Material Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for disposables, starting materials, packaging materials, intermediates, bulk and finished product. Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations. Be a primary participant in site inspection preparation, management and response process. Oversight and approval of site QC related activities: EM, release data, stability, sterile operations review. Provide strategic input on quality related business systems such as change control, deviation/CAPA, maintenance/calibration, and work orders and contribute to specifications and user requirements as well as assisting with the implementation and supporting on-going improvements. May lead the quality review of Quality Control function (QA for QC) tasked with QA oversight and support of overall facility QC related activities including environmental monitoring data review, QC lab equipment and method qualifications, QC batch release data, CofA review and approval. Qualifications Minimum B.S. degree, preferably in microbiology, chemistry or biochemistry. 10-15 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 preferred. Experience with viral gene therapies and/or orphan disease indications is a plus. 7+ years of direct supervisory experience of technical 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/facility related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence. Strong knowledge and application of the CFRs and cGMPs and have been involved in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). 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-GK1
AveXis Inc. Libertyville, IL, USA
Jul 19, 2019
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 Capital Buyer is a key member of the Supply Chain Sourcing team with global accountability responsible for working closely with Global Engineering, Site Engineering, Purchasing and Sourcing. Responsibilities Execute a capital equipment sourcing strategy and defined strategic sourcing processes. Execute bidding process, RFPs and other related functions for new equipment. Create purchase orders and manage delivery dates for equipment. Develop global and regional expertise in target commodities with a thorough understanding of demand / supply market dynamics. Demonstrate a good understanding of TCO (total cost of ownership) and various processes applicable to drive cost reductions. Attend reviews with global teams to ensure projects employ strategic approved vendors to implement supplier compression objectives. Develop and maintain relationships with plant-based engineering groups. Coordinate with key suppliers to ensure plant specific requirements are met. Drive utilization of tools and techniques that align to standardized processes. Focus on strategic suppliers / partners to drive ongoing cost reductions. Act as a liaison between suppliers and involved departments to resolve Procurement related problems. Monitor supplier performance by ensuring product is delivered as scheduled and meets specifications. Maintain appropriate files to ensure suppliers are aware of their performance. Support continuous improvement in spend and demand management processes. Develop influential and positive stakeholder relationships across the group. Qualifications Bachelor's Degree in Business, Science, Supply Chain or a related field required and 2-5 years professional purchasing experience in pharmaceutical or other regulated and GxP environment(s). Experience purchasing and sourcing capital equipment. Ability to solve problems involving several variables in fluid situations. Good communication and negotiation skills. Must be able to calculate accurate cost savings for goods and services. Must have the ability to work in or lead cross-functional teams. Lean Six Sigma, ISO 9001:2015 experience preferred. Knowledge of MRP Systems, Internet software, Order processing systems, Microsoft Office software (Excel, PowerPoint, Access, Word). Attention to detail. Able to thrive in a fast-paced environment. Knowledge of GMP Pharma/BioTech Equipment. Ability to travel approximately 20%, domestic and international as 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-JH1
AveXis Inc. Illinois, USA
Jul 19, 2019
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. Our Executive Assistant will be supporting our SVP, BD&L and Corporate Strategy. The Executive Assistant will be experienced in handling a wide range of executive support and be able to work independently with little or no supervision. Must be extremely well organized, flexible and strive under the challenges and pressure of supporting a growing organization. This candidate will need to balance multiple priorities, while remaining proactive, adaptable and efficient. Strong written and verbal communication skills, strong decision-making ability and attention to detail are extremely important in this role. Must be able to maintain confidential and sensitive information. Direct administrative support to Sr. VP and their staff to ensure productivity through routine administrative activities as well as non-routine activities and special projects. Responsibilities Complete routine/non-routine, complex projects, assignments which may include creating presentations, interview schedules, contracts or other confidential documents. Schedule and manage on-site, off-site and virtual meetings across US and international time zones. Organize and maintain logistics of business travel. Independently identify and initiate process improvement areas across departments or function with limited direction. Maintain communication with all levels of management and employees, often dealing with confidential information. Coordinate internal and external meetings, set up conference calls and in-house training/meetings. Perform special projects and/or other functions to support the business as assigned or proactively performed. Advanced technical skills with Outlook, Word, Excel, and PowerPoint. Strong organizational skills. High-level prioritizing and multi-tasking. Excellent written and verbal communication skills. Embrace the AveXis culture and model work behaviors that are consistent with each of the company's core values: Tenacity, Teamwork, and Integrity. Submit expense reports. Support AveXis Leadership Team meetings by attending and taking meeting minutes. Tact and confidentiality handling sensitive, confidential information. Qualifications At least 7 years of administrative support experience including direct support of senior leaders. Bachelor's degree highly preferred. Strong PC skills including advanced knowledge of the MS Office suite including Word, Excel, and PowerPoint. Demonstrated ability to manage a diverse workload of diverse tasks; organization and prioritization. Strong interpersonal and oral communication. High tolerance for deadlines and conflicting priorities. Team Orientation and delegation skills. Minimum 5 years' experience supporting Executive level management. Bachelor's degree or equivalent experience. 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-AM1
AveXis Inc. Illinois, USA
Jul 19, 2019
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 successful candidate will lead efforts to expand our proprietary pipeline in the areas of gene therapy and rare diseases, with a particular focus on neuroscience. Further, he or she will identify opportunities to enhance and expand our technology platforms and manufacturing capabilities. Responsibilities Define priorities to guide pipeline and platform technology investments. Scout for external opportunities in line with growth agenda, including academic partnerships, licensing and M&A opportunities. Manage the cross-functional evaluation of external opportunities with internal experts; provide recommendations based on scientific merit, patient impact and financial metrics. Advance term sheet development and negotiations, partnering with Novartis colleagues where appropriate. Present opportunities to governance committees for advancement. Attend medical and partnering conferences; advance relationships with members of the industry and academic communities to support business development objectives. Qualifications Bachelor's degree required, with minimum of 6-8 years of biopharma/biotechnology business development, venture capital, investment banking or licensing experience. Comfortable with scientific concepts; advanced degree in a scientific field (MD, PhD) preferred. Robust working knowledge of gene therapy and/or neuroscience therapeutic area preferred. Strong leadership, scientific, organizational, communication, and project management skills and ability to manage multiple projects simultaneously. Financial acumen; comfortable with financial valuations and modeling. Excellent presentation and communication skills. Demonstrated ability to foresee and solve problems and prioritize and meet deadlines. Experience in successfully managing teams at all levels of staff and across differing functional expertise. Professional demeanor with strong decision-making ability. 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-AM1
AveXis Inc. Libertyville, IL, USA
Jul 19, 2019
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 Engineer is responsible for leading process development and improvement activities for the Drug Product/Fill-Finish manufacturing processes used to manufacture AveXis gene therapy products. This individual will define and direct the activity with internal and external organizations to plan, execute, and document early manufacturing that define the product and process of new AveXis gene therapy candidates. This individual will be responsible for the collection and interpretation of data and collaboration with other departments on manufacturing and product compatibility related issues to drive resolution and process improvements. The Senior Engineer will perform development experiments and oversee the data and reports to support regulatory applications. Responsibilities Serve as a key scientific and technical lead for Drug Product/Fill-Finish processes at internal and external manufacturing facilities. Partner with Manufacturing and Quality to meet the production schedule, ensure clinical/commercial supply and uphold quality standards. Provide technical/scientific support in process development and qualification efforts for clinical and commercial launch, i.e. material compatibility studies, product stability, process and shipping qualification, etc. Support regulatory applications as subject matter expert for Drug Product/Fill-Finish operations and process development experiments. Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Seek operational excellence and continuous improvement opportunities and implement potential process improvements in conjunction with operations. Support tech transfer and start-up efforts of new products and equipment into GMP manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support. Qualifications PhD in biochemistry, chemical engineering, bioengineering, or related technical field OR M.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 3 years of experience in support of biopharmaceutical manufacturing OR B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 5 years of experience in support of biopharmaceutical manufacturing. Excellent oral and written communication skills. 5-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in sterile filtration and aseptic fill-finish. Familiar with global regulations on devices, drugs, validation/qualification requirements. Strong technical writing ability. Proven ability to effectively lead and participate on teams. Up to 50% travel may be 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-JH1
AveXis Inc. Illinois, USA
Jul 19, 2019
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 Associate Director of Medical Information reports to the Senior Director of Global Medical Information and oversees the provision of technical and medical information with high quality customer service, researches and prepares responses for escalated medical inquiries as well as Scientific Response Documents related to multiple or assigned therapeutic areas. Responsibilities Supports all medical information deliverables. Supports the development of Medical Information content (e.g. SRLs, FAQs, Medical and Promotional Review content, and Literature Searches). Ensures that content allows for scientific exchange (non-promotional, truthful, and fair and balanced). Supports vendor management and holds vendor accountable to pre-defined time, cost, and quality deliverables. Supports system to manage medical inquiries to Field Based Medical and Commercial teams. Authors insight reports based on medical inquiries received. Collaborates with pharmacovigilance and product supply to ensure timely processing of potential safety and product compliant issues. Supports compliance of corporate policies and procedures, as well as, US healthcare laws and regulations. Qualifications MD, PhD or PharmD required. 5 - 10 years' experience in medical information; or equivalent experience; Neurology experience preferred. Proven track record of successful medical information in prior biopharmaceutical companies; ideally in a small company environment; can easily point to examples including applying IT solutions fulfill medical information requests and manage medical information capabilities. Occasional travel (up to 30%) for conferences and meetings. Successful experience in fast-paced entrepreneurial environment. Fit with AveXis culture and values. Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices. Maintains a positive and professional demeanor toward all customers and coworkers. Adheres to all policies and procedures of AveXis. Performs other duties as assigned. 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-EC1
AveXis Inc. Illinois, USA
Jul 19, 2019
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 Manager of Medical Information reports to the Director or Senior Director of Global Medical Information and supports the provision of technical and medical information with high quality customer service, researches and prepares responses for escalated medical inquiries as well as Scientific Response Documents related to multiple or assigned therapeutic areas. Responsibilities Collaborates with Medical Information leadership to manage medical information deliverables. Supports the development of Medical Information content (e.g. SRLs, FAQs and Literature Searches). Ensures that content allows for scientific exchange (non-promotional, truthful, and fair and balanced). Supports system to manage medical inquiries to Field Based Medical Teams. Supports insight reports based on medical inquiries received. Supports pharmacovigilance and product supply functions to ensure timely processing of potential safety and product compliant issues. Supports compliance with corporate policies and procedures, as well as, US healthcare laws and regulations. Qualifications PhD or PharmD required. 3 - 5 years' experience in medical information; or equivalent experience; Neurology experience preferred, including a residency program in Medical Information. Proven track record of successful medical information in prior biopharmaceutical companies; ideally in a small company environment; can easily point to examples including applying IT solutions fulfill medical information requests and manage medical information capabilities. Occasional travel (up to 20%) for conferences and meetings. Successful experience in fast-paced entrepreneurial environment. Fit with AveXis culture and values. Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices. Maintains a positive and professional demeanor toward all customers and coworkers. Adheres to all policies and procedures of AveXis. Performs other duties as assigned 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-EC1
AveXis Inc. Durham, NC, USA
Jul 18, 2019
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 Director, Quality Operations (SD, QO) provides leadership and coordination for the AveXis Global Quality Leadership Team (GQLT) and is the primary operational link for the GQLT to operations program management activity. The SD, QO takes ownership of the development and implementation of the Quality Strategy for AveXis, working closely with peer members of the GQLT. In so doing, the SD, QO ensures that AveXis meets its strategic and tactical goals. This person also serves in a trusted support role to the SVP Quality and to the extended Quality leadership. This person provides senior direction to a wide range of initiatives and activities, representing the global interests of Quality Operations (i.e. Quality Site Heads and other leaders with operational responsibility). The SD, QO plans work management and identifies risks to success and owns the risk register for Quality Operations. The SD, QO also acts as the owner of the Global Quality Management Review process, working with senior stakeholders such as the VP of Manufacturing, VP of MSAT, site heads and senior Quality leaders to ensure that the Global QMR process functions effectively. Responsibilities Establish and Lead the Quality Operations Forum. Work with Quality Operations peers to establish a forum and working processes to ensure that: AveXis operations are maintained as common platform activity at the global level. Operational initiatives and activities are planned, tracked and effectively managed. Quality group activities and requirements are integrated to site and global plans (including timeline, resource and budget plans). Sites are adequately supported and cooperate and share resource for the optimum outcome for AveXis. Work with Global Quality Systems leaders to ensure that Operational activity and requirements are fully aligned and integrated with the AveXis Global Quality System. Establish an integrated Quality Risk Register: Create and maintain an integrated Risk Register for Global Quality. Own and operate the process for Quality Risk Management, ensuring that risk management is integrated with AveXis Quality Strategy and Activity. Coordinate and Facilitate Talent Development and Management for Global Quality: Establish leadership team processes and practices to ensure that the Quality function adopts and operates a best-in-class program for talent development and management. Work with colleagues in other AveXis functions and the wider Novartis network to ensure the best possible talent is available to Global Quality and AveXis. Maintain and improve communication structure and program/project management tools: Work with Technical Operations (TO) colleagues to ensure the communication structure is optimized, and program tools and activity are effective. Work with TO Program management to jointly own and operate the jointly sponsored Process Review Board/ Technical Review Board governance process. Execute and track against Corporate Goals and Key Objectives: Facilitate the goal setting process and prioritize projects and tasks to ensure corporate commitments are met. Provide additional support to SVP, Quality including strategic evaluations, town hall materials, special projects, etc. Qualifications Minimum B.S. degree in science related field; higher level degree: MS, MBA preferred but not required. PMP Certification preferred but not required. 12-15 years' experience in manufacturing, quality, and contract supplier/customer interactions with progressively expanding leadership roles; BLA/MAA and PAI experience preferred. Strong project management, budget, and presentation skills. Ability to synthesize detailed information and provide critical insights across manufacturing and supply chain. Knowledge and understanding of cGMPs. 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.
AveXis Inc. Illinois, USA
Jul 18, 2019
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. AveXis is seeking a positive, high-energy and agile payer marketer who will be responsible for the development and execution of initiatives aimed at US Payers and Healthcare Professionals. The Senior Manager will play a key role in supporting Payer Marketing and the Market Access team. They will be responsible for the management of day-to-day business activities as well as delivering key payer marketing support for product label expansions and launch initiatives. The position requires a highly motivated individual who can work independently, think strategically, and collaborate transversally to accomplish complex deliverables. Responsibilities Assist in development and refinement of strategy for new product launches and label expansions, with flawless execution of key payer marketing initiatives across the AveXis portfolio. Work with cross-functional colleagues from HEOR, Brand Marketing, Global Marketing and creative agencies to help generate key messages and tactics to support continued broad U.S. access as well as successful launches and expansions. Supports payer marketing efforts to support the Market Access field teams in customer strategy, planning and execution (e.g., training, account management tools/resources, and POA needs). Lead all payer pull-through initiatives, including design and implementation of key field access tools and resources. Plan and oversee execution of activities related to market access and payer-related congresses. Develops insights, strategies, and tactics for reimbursement, distribution, and access to include, but not limited to coverage dashboards, access website support, payer team tools, provider access tools, sales team messaging and access-related sales tools. Manage relationships with strategic partners and vendors (includes market access agencies) to ensure that projects are completed in a timely and efficient manner while remaining on budget; condition partners for executional excellence and hold them accountable to success metrics. Manage vendor contract processing (purchasing requisitions, invoices, and approvals) Manage sponsored laboratory testing programs to facilitate diagnosis of rare diseases and treatment with gene therapies. Support the development and deployment of payer marketing unbranded and branded initiatives including objective setting, content development, internal Promotional Review Committee (PRC) review, QC, production, deployment/distribution to the field and performance measurement. Collaborate with multiple functional groups across the organization, including but not limited to Sales, Regulatory, Market Access, Market Research, Commercial Operations, Legal, Patient Advocacy, and Medical Affairs. Qualifications BA/BS degree in biological sciences, pharmacy, marketing or business administration or a minimum of 7 years of related experience in a prior role; Minimum 4-5 years of US pharmaceutical brand marketing experience. US Launch experience in orphan and/or CNS preferred. Ability to quickly understand and communicate all clinical data / publications to support business objectives. Strong market access background with emphasis on payer analytics. Proven ability to work under pressure, prioritize and manage multiple projects, and effectively influence, collaborate, and communicate with internal and external partners. Experience working with external brand agencies and vendors on a day-to-day basis. Demonstrated financial and business acumen. A high interest in working in a "roll up the sleeves" environment of a small bio-pharma company. Up to 25% of US domestic 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-AM1
AveXis Inc. Durham, NC, USA
Jul 18, 2019
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 Principal Engineer/Scientist is responsible for defining and leading development and improvement activities for the manufacturing processes used to manufacture AveXis gene therapy products at teh Durham, NC site. This individual will be responsible for the process related aspects of the downstream process and/or the technical transfer of new drug entities to the Durham site utilizing the platform gene therapy process. In addition, this individual will lead a cross functional teams for downstream process improvements and/or tech transfers to the site while serving as the technical lead. Responsibilities Act as a scientific and technical lead for process-related issues and investigations at the facility. Partner with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards. Mentor and train engineering team members. Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Define potential process improvements in conjunction with the Global process owners and operations and lead implementation of process changes. Participate in start-up efforts of new equipment, software or processes in manufacturing. Develop, communicate, and implement strategic planning for business development and future improvements. Assist in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Provide technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc. Utilize 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. Build strong relationships with Quality to ensure a compliant manufacturing environment. Assist the technical operations team in resolving any issues related to production. Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support. Qualifications PhD in biochemistry, chemical engineering, bioengineering, or 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 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 related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing. Excellent oral and written communication skills. Experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish. Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements. Strong technical writing ability. Proven ability to effectively lead and participate on teams. Leadership of technical staff either directly or in a matrix organization. Up to 25% travel may be required. Position will be based at Durham, NC site. 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-GK1
AveXis Inc. Durham, NC, USA
Jul 18, 2019
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 Engineer is responsible for leading development and improvement activities for the drug substance and drug product manufacturing processes used to manufacture AveXis gene therapy products at the Durham, NC site. This individual will be responsible for the process related aspects of the downstream process and/or the technical transfer of new drug entities to the Durham site utilizing the platform gene therapy process. This individual will also be responsible for collaboration with other departments on manufacturing related issues to drive resolution and process improvements. Responsibilities Serve as a scientific and technical lead for product process-related issues and investigations at the facility. Partner with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards. Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Implement potential process improvements in conjunction with operations. Participate in start-up efforts of new equipment, software or processes in manufacturing. Assist in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Provide technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports. Utilize small-scale production processes and scaled-down lab processes to enable process troubleshooting, with the potential to oversee these experiments at external partners. 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 compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support. Qualifications PhD in biochemistry, chemical engineering, bioengineering, or related technical field OR Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 2 years of experience in support of biopharmaceutical manufacturing OR Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 4 years of experience in support of biopharmaceutical manufacturing. Excellent oral and written communication skills. Preferred Experience: 5-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish, additional experience in cell culture, recovery, or purification Familiar with global regulations on devices, drugs, validation/qualification requirements Strong technical writing ability Proven ability to effectively lead and participate on teams Up to 25% travel may be 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-GK1
AveXis Inc. Durham, NC, USA
Jul 18, 2019
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 Director, Quality Operations (SD, QO) provides leadership and coordination for the AveXis Global Quality Leadership Team (GQLT) and is the primary operational link for the GQLT to operations program management activity. The SD, QO takes ownership of the development and implementation of the Quality Strategy for AveXis, working closely with peer members of the GQLT. In so doing, the SD, QO ensures that AveXis meets its strategic and tactical goals. This person also serves in a trusted support role to the SVP Quality and to the extended Quality leadership. This person provides senior direction to a wide range of initiatives and activities, representing the global interests of Quality Operations (i.e. Quality Site Heads and other leaders with operational responsibility). The SD, QO plans work management and identifies risks to success and owns the risk register for Quality Operations. The SD, QO also acts as the owner of the Global Quality Management Review process, working with senior stakeholders such as the VP of Manufacturing, VP of MSAT, site heads and senior Quality leaders to ensure that the Global QMR process functions effectively. Responsibilities Establish and Lead the Quality Operations Forum. Work with Quality Operations peers to establish a forum and working processes to ensure that: AveXis operations are maintained as common platform activity at the global level. Operational initiatives and activities are planned, tracked and effectively managed. Quality group activities and requirements are integrated to site and global plans (including timeline, resource and budget plans). Sites are adequately supported and cooperate and share resource for the optimum outcome for AveXis. Work with Global Quality Systems leaders to ensure that Operational activity and requirements are fully aligned and integrated with the AveXis Global Quality System. Establish an integrated Quality Risk Register: Create and maintain an integrated Risk Register for Global Quality. Own and operate the process for Quality Risk Management, ensuring that risk management is integrated with AveXis Quality Strategy and Activity. Coordinate and Facilitate Talent Development and Management for Global Quality: Establish leadership team processes and practices to ensure that the Quality function adopts and operates a best-in-class program for talent development and management. Work with colleagues in other AveXis functions and the wider Novartis network to ensure the best possible talent is available to Global Quality and AveXis. Maintain and improve communication structure and program/project management tools: Work with Technical Operations (TO) colleagues to ensure the communication structure is optimized, and program tools and activity are effective. Work with TO Program management to jointly own and operate the jointly sponsored Process Review Board/ Technical Review Board governance process. Execute and track against Corporate Goals and Key Objectives: Facilitate the goal setting process and prioritize projects and tasks to ensure corporate commitments are met. Provide additional support to SVP, Quality including strategic evaluations, town hall materials, special projects, etc. Qualifications Minimum B.S. degree in science related field; higher level degree: MS, MBA preferred but not required. PMP Certification preferred but not required. 12-15 years' experience in manufacturing, quality, and contract supplier/customer interactions with progressively expanding leadership roles; BLA/MAA and PAI experience preferred. Strong project management, budget, and presentation skills. Ability to synthesize detailed information and provide critical insights across manufacturing and supply chain. Knowledge and understanding of cGMPs. 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.
AveXis Inc. Durham, NC, USA
Jul 18, 2019
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. AveXis is seeking a highly motivated individual to join us as a Quality Control (QC) Senior Microbiologist. This position works with the Quality Control team supporting our efforts in this exciting new area of gene therapy. This role will be responsible for providing technical support to QC and Manufacturing related to Environmental Monitoring (EM) and Sterility Assurance. Responsibilities Partner with Manufacturing and Facilities to address facility environmental and utilities excursions. Support resolution of problems identifying trends and determining system improvements. Review and approve investigations related to environmental excursions. Generate metrics and oversee environmental monitoring trends and reports. Oversee environmental monitoring risk assessments. Oversee annual alert level assessments. Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans. Partner with Manufacturing to champion the company's compliance to aseptic procedures and practices in accordance with current regulatory requirements and industry guidance. Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations. Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state. Develop, revise and review SOPs, qualification/validation protocols and reports. Train staff on technical concepts and methods. Review laboratory data. Perform other duties as assigned. Qualifications Bachelor's degree or advanced degree in Microbiology or related discipline. A minimum of 8 years' experience working in a GMP QC Microbiology/Environmental Monitoring laboratories, preferably in an aseptic processing facility. A minimum of 3 years' experience with Environmental Monitoring investigations. Ability to gown for entry into Aseptic core and supporting areas and lift approximately 25 pounds. Well versed in various environmental monitoring techniques including rapid methods, and qualifying environmental monitoring processes with reference to cell and gene therapy products. Must be familiar with implementation of microbiological environmental monitoring programs and must understand interpretation of microbiological data including evaluation of trends. Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/, ISO 14644-1, USP, EP). Experience in performing EM risk assessments. Extensive experience in conducting laboratory and environmental excursion investigations. Strong knowledge of equipment IQ/OQ/PQ/PV. Proficient in MS Word, Excel, Power Point and other applications. Excellent interpersonal, verbal and written communication skills. Ability to communicate and work independently with scientific/technical personnel. Self-motivated, detail-oriented, comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Experience managing projects. Experience drafting qualification/validation protocols and reports. Experience executing equipment and method qualifications independently. 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-TT1
AveXis Inc. Illinois, USA
Jul 17, 2019
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 Director, Program Management has strong drug development knowledge and provides cross-functional leadership for one or more Program Teams. They are responsible for driving the integrated strategy and development plan, ensuring overall organizational alignment, and driving seamless cross-functional execution. The Senior Director, Program Management key accountabilities include defining overall program strategy, integrated development plan, high-level program timelines, proactively identifying and managing program development risks and issues, and ensuring effective Program Team dynamics, performance, prioritization and communication. They are a recognized thought leader in program management topics. They will establish Program Management process and tools, risk assessment, mitigation, and strategic planning, with regards to resources, cross-functional plans and timelines across all programs. Responsibilities In partnership with the Chief Regulatory Officer and Regulatory Team members, drives development of regulatory strategy into an integrated regulatory development plan and ensures consistency with the target product profile. Accountable for high-quality program team communication. Organizes Regulatory Team meetings and prepares high quality agendas and minutes in a timely manner. Responsible for the quality of the integrated regulatory development plan, alignment with cross-functional plans and alignment with the target product profile Communicates regulatory program status and issues horizontally and vertically in a transparent and timely manner Drives development of strategic regulatory documents, drives discussions that need escalation to PSC and prepares update presentations for ALT, as needed Supports Chief Regulatory Officer in driving preparation of comprehensive regulatory communications with Novartis, as needed Drives risk assessment and contingency planning within Regulatory Affairs Independently leads ad-hoc cross-functional sub-teams and task forces to address and resolve regulatory issues Identify resources gaps and work with the functions to bridge any gaps to prevent timeline impact Proactively identify potential issues and work to remove barriers; escalate issues appropriately that cannot be directly resolved. Enables a high-performing team culture based on Teamwork, Tenacity and Integrity, and holds team members accountable for representing their respective functions Collaborate with Team members to establish effective, productive, trusting relationships Drive Team effectiveness by setting and communicating clear expectations on deliverables, roles and responsibilities, and by promoting Team cohesiveness. Coaches regulatory team members, as needed, for optimal team performance Provides Regulatory Project Management Leadership Mentors others on program/project management topics Provides program management expertise and leadership in the areas of planning, tracking, scenario-generation, contingency development, critical path analysis, and risk management within Regulatory Affairs Actively identifies and develops best practices for project management and implements accordingly Qualifications An undergraduate degree in an area related to life sciences. A graduate degree such as a PhD, PharmD, or MBA is highly desired; a PMP designation is preferred. A minimum of 10+ years of drug development experience, preferably at a company focused on orphan or rare disease drugs. A minimum of 6+ years of cross-functional leadership experience. Expert knowledge in drug development; exposure to the success and failure of drug candidates; ability to be creative and think outside of the box regarding the path to commercialization. Excellent project/program management skills; advanced planning and tracking skills; ability to use proper tools for risk management. Strong team facilitation skills, including negotiation and conflict resolution skills; expert in communication and information management. An innovative thinker, with a track record for translating strategic thinking into action plans and output. Strong leadership presence with the ability to present and interact with senior management; demonstrated political savvy. Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment. Energetic, flexible, collaborative and proactive; a team leader who can positively and productively impact initiatives. 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-EC1