AveXis Inc.

AveXis Inc. Illinois, USA
May 23, 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 of Safety Operations reports to the Global Head of Patient Safety. The Director will be responsible for creating, directing and managing the company's infrastructure and staff to support the operational aspects of the pharmacovigilance system, and adheres to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to overall global safety operations strategy across the portfolio including AveXis case management, database strategy, vendor oversight, compliance, inspection readiness, budget, contracts and training. Responsibilities Provide strategic planning, implementation, and management of Global Patient Safety (GPS) Pharmacovigilance Operations activities. Responsible for managing internal and external staff allocated to operational GPS activities, creating a highly efficient team across insourced and outsourced resources. Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP). Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations. Ensures that the GPS Database supports the department needs, including specific workflows and reporting/querying functionalities. Provides oversight of systems and MedDRA updates in collaboration with the relevant vendor(s). Manage vendors and business partners. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics. Develop and implement an inspection readiness program with the contribution of other GPS and non-PV stakeholders. Responsible for a compliant and quality execution of all operational activities related to case management and related activities. Oversees timely submissions of expedited reports to the FDA & other health authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level. Establish a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the AveXis Quality group. Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products. Contributes to, drafts and implements department SOPs and work instructions related to the GPS activities. Oversee to the signal detection, benefit-risk profile assessment, risk management and aggregate reporting activities with providing accurate reports from the GPS database. Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices. Represents GPS as a leader on project teams, other departments, and committees as needed. Qualifications Training in relevant subject, life science degree, and or Post-graduate specialization in project or business management. Min 5-10 years' experience in the pharmaceutical industry, predominately in drug safety/pharmacovigilance operations, having worked on both development and marketed products. Demonstrated leadership in building safety operations function and experience in vendor management. Experience of working in a cross functional team and strong project and business management skills. Experience in managing and supervising team is preferred. Credible knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes. Strong organizational, planning, prioritizing and problem-solving skills. Effective multi-tasking skills, applied in different and complex assignments and ability to work effectively under pressure and under strict timelines. Ability to work both independently and collaboratively and use own initiative. Ability to communicate effectively both locally and globally, internally and externally. Operational expertise in ARGUS preferred. Proficient MS Office skills. Personality and attitude. Approachable, flexible and self-motivated. Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements. Tolerance for ambiguity and ability to adapt quickly to a changing business environment. Highly resilient, tenacious and resourceful. Occasional travel (up to 20%) for business and meetings. High attention to details. 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
May 23, 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 Manager Cost Accountant is an integral member of the Manufacturing site with responsibility for inventory accounting, monthly manufacturing close, analysis of variances, and the annual standard setting process. The Manager Cost Accountant will work closely with the Plant Controller as well as operations personnel providing budget support and offering financial counsel. Responsibilities Lead the implementation and maintenance of inventory and cost accounting systems and procedures. Own the month-end close process providing explanations for actual versus forecast results and reliable reports with which to measure the performance of each operation against established plans and forecasts. Assist with the annual budgeting process and development of quarterly rolling forecasts. Act as a key contributor in the development of standard costs and ensuring the accuracy and reliability of the Company's standard cost and inventory valuation systems and procedures. Embrace the AveXis culture and model work behaviors that are consistent with each of the company's core values: Tenacity, Teamwork, and Integrity. Qualifications Bachelor's degree in Finance or Accounting is required; CPA, CFA, CMA, or MBA a plus. A minimum of 5 years experience of increasing responsibility across financial disciplines including a minimum of 2 years' experience in cost accounting with responsibility for setting standard costs and analyzing manufacturing variances. Pharmaceutical or biotech experience preferred. Advanced abilities in Excel and database management. Proven knowledge of US GAAP, accounting principles, practices, standards and regulations. Experience with ERP systems required; experience with ERP system implementation a plus. Ability to communicate effectively with senior leaders and collaborate with staff at all organizational levels across various business units is required. Ability to thrive in a fast-paced ever-changing environment. Must have discretion with handling confidential or sensitive information. 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. Maryland, USA
May 23, 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. AveXis is seeking a Project Manager to provide support to Clinical and External Manufacturing Partners. Must be highly motivated, organized, solution-oriented, and efficient with strong technical aptitude and the ability to work effectively with multiple team members. This will be a fast-paced role within a cross functional project team. Responsibilities Clinical Supply: Supports strategic goal to deliver multiple blockbuster rare disease launches by managing scale-up strategy and implementation for new product introductions to CMO partners. Leverages AveXis' scalable manufacturing platform to support IND-enabling clinical program timelines. Ensures efficient, reliable and cost-effective agreements. Works closely with external manufacturing partners (i.e Plasmid suppliers) to develop project plans, risk mitigation strategies and timelines/milestones. Understands current and future external Clinical supply needs and maximizes supplier utilization to short- and long-term demand. Contract management: Manages contractual obligations advising collaboration participants on how the partnership contract should be implemented. Progress monitoring: Tracks progress, including coordinating the definition and reporting of the KPIs, as well as leading periodic health checks (e.g. Steering committee meetings). Process management: Ensures smooth operation of external collaborations, such as project team meetings, data exchange, and other kinds of interactions. Alignment and relationship building: Supports efforts to increase alignment and mutual understanding between collaboration participants. Interfaces with functional group leaders including Engineering, Manufacturing, Quality Control, Quality Assurance, and Supply Chain to ensure aligned strategies and timelines. Manages project meeting content, project objectives and progress to ensure adherence to project plans. Supports the PMO group for any technology transfer activities. Owns manufacturing process related change controls. Reports on project progress identifying issues and risks and offering viable solutions and opportunities as they arise. Leads meetings with workstream leaders and sets expectations for project teams. Qualifications Bachelor's degree and 10 years of relevant experience. PMP certification desired. Proven ability to manage multiple high-level parallel tasks effectively using technology (i.e. MS Project, Power Point), work unsupervised and possess the ability to apply new techniques using strong prioritization skills. Must display effective planning, organizational, and critical thinking skills, innovativeness, and keen attention to detail and excellent follow through. The incumbent must have strong interpersonal skills. Approximately 50% 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-JH1
AveXis Inc. Durham, NC, USA
May 23, 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. This position is responsible for supervising the cleaning team of the ISO classified clean rooms and associated activities as directed. Primary responsibilities include supervision of cleaning staff in applying cleaning solution to floors, ceilings, walls, fixtures, and equipment in conjunction with the proper cleaning equipment such as mops, wipes, bucket system, etc. following approved cleaning standard operating procedure. Individual will be directly responsible for a team of contractors whose direct responsibilities include performing GMP cleanings of different ISO clean room rated areas. The manufacturing supervisor will be the first line of contact to handle emergencies and perform routine inspections. Responsibilities Ensure daily, weekly, and monthly cleaning of the clean rooms that include all classified areas using specified cleaning chemicals and is compliant with cGMPs and safety regulations. Point person on shift to assign/distribute the work and coordinate emergency situations. Lead investigations as related to GMP cleaning activities. Author deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly. Ensure documentation (logbooks) are accurate and updated as required. Ensure that all Standard Operating Procedures (SOPs) are followed and that all cleaning, disinfecting and documentation expectations adhere to the Good Manufacturing Practices (GMP) and Good Documentation practices (GDP). This role is responsible for the accurate, safe, environmentally responsible, and quality compliant operations per cGMP expectations and SOPs. Identify and implement opportunities to improve GMP cleanings. Understand and be able to prepare chemicals properly and understand the contact time for all chemicals. Read and understand all revisions of applicable assigned SOPs, policies and procedures. Complete all training requirements for specific work areas and Maintain all training requirements for staff. Interview and oversee contract employees. Communicate and resolve issues that present themselves. Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions). Lead and mentor staff. Handle HR related matters and communicate those issues effectively to the contractor. Work flexible hours including holidays, weekends, overtime and special assignments. Qualifications Previous supervisory experience and demonstrated ability to lead a team preferred. Minimum High School diploma or equivalent. A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing cleaning operations. Solid knowledge of FDA regulations and GMP systems. Excellent oral and written communication skills. Strong technical writing ability preferred. Ability to don sterile protective equipment for entry into the cleanrooms. Previous Aseptic cleaning experience. Must be able to lift over 35lbs and stand for extended periods of time. 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
May 23, 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 Engineer is responsible for assisting with the development and improvement activities for the drug product manufacturing processes used to manufacture AveXis gene therapy products at a site. This individual will support the collection and interpretation of continued process verification data and collaborate with other departments on manufacturing related issues to drive resolution and process improvements. Responsibilities Serve as a scientific and technical representative for drug 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. 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. Complete requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support. Qualifications Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field. Additional experience may be used to substitute for non-technical degrees. Excellent oral and written communication skills. Preferred Experience 2-5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish. Additional experience in cell culture, recovery, or purification is also beneficial Familiar with global regulations on devices, drugs, 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-RL1
AveXis Inc. Longmont, CO, USA
May 23, 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. AveXis is seeking a Process Engineer - Plant Utilities/Electrical Engineer for the overall performance and monitoring of Black Utility Systems. Responsible for providing operational and project support for Plant utility systems. The operational support will include equipment/system troubleshooting and providing in-house engineering expertise to the maintenance and manufacturing staff. The primary focus of the position is on plant/electrical utilities and operations (Industrial Steam, Chilled Water, Clean Compressed Air, Hot Water, Electrical, and Waste Water System). All system improvements will be made in conjunction with Manufacturing, Facilities, Validation, Quality Assurance, and Regulatory. Responsibilities Act as subject matter expert (SME) and system owner for the following systems: Plant Steam, Chilled Water, Clean Compressed Air, and Electrical distribution for GMP and non-GMP environment. Black utilities including Boilers, Chillers, Cooling Towers, Air Compressors, Air Dryers, Pumps, Emergency Generators, and Electrical Switchboard System. Troubleshoot issues, determining root cause of problems and provide optimization strategies for utility systems. Provide imaginative, thorough and practicable solutions to a wide range of difficult problems. Develop alternative courses of action that are based on logical assumptions, factual data and engineering principles. Troubleshoot support for complex utility equipment problems as elevated by the plant manufacturing and facilities customer(s). Accountable for all phases of the Change Control process for owned changes. Owns and ensures timely closure of plant equipment and system related CAPAs. Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols). Read and understand mechanical, electrical, and P&ID drawings. Qualifications Bachelor's degree in Chemical, Electrical, or Mechanical/Civil Engineering, or related field or equivalent experience required. PE license is desirable. Minimum 5-8 years of experience with clean utility systems, preferably in a regulated environment. Demonstrated ability to work and collaborate in cross functional teams, research development, manufacturing 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-RL1
AveXis Inc. Longmont, CO, USA
May 23, 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. This role will be responsible for leading a group of quality analysts, managing the day to day oversight and development of functions within the Quality Control Microbiology team. The scope of oversight may include aspects of general Microbiology support programs and functions, environmental monitoring, utility monitoring, raw material testing, in-process and final product testing, media qualification, culture maintenance, microbial identification, contract lab testing, and other functions within the QC Microbiology laboratory. Responsibilities Foster engaging and inclusive culture, focused on serving patients and team. Maintains strong presence in the laboratory and on-the-floor as required to support team and customers. Management of Quality Control Microbiology laboratory functions and team. Recruits, develops, and mentors staff and provides support to ensure successful accomplishment of business goals. Establish and continuously improve department business processes to ensure all business and customer requirements are met. Manage performance and development for the team, including goal setting and monitoring, ongoing feedback, and performance evaluations. Manage sample receipt, retain storage, and disposal. Manage and optimize responsible microbiology functions/programs. Implement and manage Lean Lab and continuous improvement methodologies and practices. Establish, manage and continuously evaluate and improve staff and department training programs and materials. Provide guidance and oversight of Out of Specification, Out of Trend, and Unexpected Results, laboratory investigations, non-conformance records, CAPAs, and Change Controls. Participate in Microbiology program data trending evaluation and review, as required. Develop, revise, and review SOPs, qualification/validation protocols and reports, and technical documents, as required. Provide support as department head designee, as required. Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Gather metric information for use in continuous improvement of responsible areas. Other duties as required. Qualifications Bachelor's degree or advanced degree in Microbiology or related discipline. Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment. A minimum of 8 years' experience working in a GMP Quality Control laboratory, with extensive experience in Microbiology preferred. A minimum of 3 years' experience supervising/managing in a GMP Quality Control biotechnology or pharmaceutical industry laboratory, microbiology laboratory preferred. Well versed in various microbiological techniques. This experience may be in the application of microbiological techniques in facility monitoring, in-process and release testing, and/or general Microbiology lab support functions. Examples of techniques may include air monitoring, water testing, surface monitoring, genus and species identification of various microbes, media qualification, in-process and release methodologies, adventitious agent testing, sterility, culture qualification and maintenance. Requires the ability to gown for entry into Aseptic core and supporting areas, on an as-needed basis for support. Strong knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211). Strong knowledge of GMPs, GDPs, SOPs, and quality control processes. Strong data integrity knowledge and practices. Working knowledge of contamination control, disinfection, cleanroom design and operation, aseptic techniques. Proficient in MS Word, Excel, Power Point and other applications. Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Must be capable of carrying up to approximately 25 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RL1
AveXis Inc. Libertyville, IL, USA
May 23, 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. This position in Global Engineering Projects (GEP) is responsible for managing the project controls team and delivering services in support of the capitol portfolio. As part of the GEP team, this position can be based in our Libertyville Illinois, Durham North Carolina, San Diego California, or Longmont Colorado facilities. The Project Controls Senior Manager will be responsible for developing and maintain programs for engineering project budgeting, cashflow, benchmarking, and reporting. This role will manage and assign staff to engineering projects in support the capitol portfolio. In addition, they will review and analyze engineering and contractor cost estimates, bids, change orders, invoices, labor rates, physical engineering/construction progress (earned value). Responsibilities Responsible for the development, implementation, and execution of all estimating, cost control, cost reporting, scheduling and underlying procedures and systems. Ensure that proper systems are developed, maintained and employed that provide project and operational management the required tools to manage multiple capital projects. Development of the cost and work breakdown structure that converts the estimating data into a work breakdown structure, cost control, forecasting, reporting, scheduling / resource planning systems, change management and basis of quantity management. Assist in the development of project specific tools to forecast quantity, hours, cost and track changes from conceptual estimates through the execution of the project. Assist in the project set-up and close-out work process to ensure adherence to Company standards and contractual requirements. Participate in project level revenue recognition exercises, ensuring practices are aligned with management expectations. Participate in preparation of monthly and quarterly project reviews and forecasting. Interface with interdepartmental and home office to define site project reporting structure and reporting requirements. Ensure all capital projects are adequately staffed. Review and approve monthly/quarterly cost reports. Review approve and audit project estimates and budgets. Liaise with construction management companies to ensure alignment of cost reports. Drive operational excellence and continuous improvement. Qualifications Bachelor's degree from accredited institution, or 4 years of equivalent work experience AND A minimum of 10 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in facility build, equipment procurement, capital budget management, and asset lifecycle management. Proven management skills. Experience in the construction of biotech or pharmaceutical facilities. Strong technical knowledge in construction cost and schedule management. Strong analytical skills for estimate analysis, bid evaluations, budget monitoring, cashflow analysis, risk analysis and benchmarking project costs. Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Flexibility to travel as needed up to 25%. 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. Libertyville, IL, USA
May 23, 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. As part of the Quality Control organization, the Investigations Supervisor will be responsible for oversight of the investigations and completion of QC non-conformances aimed at identification of root cause, assessing potential impact as well as implementation of corrective actions and preventive actions. The Investigations Supervisor will oversee the initiation and execution of QC non-conformances in a timely fashion and in compliance with site procedures. The successful candidate will work in a cGXP environment and must have working knowledge of biopharmaceutical laboratory processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded while performing investigations. The Investigations supervisor must have the ability to understand and problem solve in an environment that is focused heavily on Chemical and Biological issues. Responsibilities Authoring and managing minor, major, and critical investigation reports related to QC testing Laboratory Investigations (LI) and non-conformances. Perform appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams). Assign and implement proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events. Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events. Remain current in regulatory expectations and industry practices regarding investigations, change controls and CAPAs. Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. Track, trend and facilitate QC related deviations, investigations, change controls and CAPAs. Perform and conduct risk assessments. Support strategic proposals, progress updates and presentations to all levels of the site organization. Qualifications Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience. Prior supervisory experience is preferred. Prior experience in quality investigations and deviation writing in a QC environment required. Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure. Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting. Must be proactive, action oriented, and have the ability to adapt to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track. Must have strong communication skills both verbally and written. Must have proven logic and decision-making abilities, critical thinking skills. Must be able to accommodate testing schedule as required. Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills. Six Sigma Yellow, Green or Black Belt certification is preferred. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
AveXis Inc. Illinois, USA
May 23, 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 will be responsible for creating, directing and managing Global Patient Safety (GPS) day to day business and projects and will collaborate with functional heads within GPS and cross-functional teams to support the operational aspects of the pharmacovigilance (PV) department. The individual will be the GPS point of contact and liaison for cross-departmental projects and activities. The qualified candidate will have experience in business and project management and perform program management related to overall global patient safety (GPS) strategy across the portfolio including managing business partners, third party vendors, budget, meetings and other GPS initiatives. Responsibilities Provide strategic planning, implementation, and management of Drug Safety and Pharmacovigilance activities for AveXis. Project management of all GPS projects including collaborative projects with Novartis, clinical safety data migration and other GPS initiatives. Point of contact for GPS projects and tracking of deliverables (e.g. aggregate reports, risk management, SOPs). Manage PV vendors and business partners. Collaborate with PV quality and compliance team in establishing and monitoring key quality and compliance metrics. Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices. Project management of EU and other regional launch readiness. Project management of Argus clinical safety data migrations to Novartis from CROs. GPS point of contact for cross-departmental projects including CMO, Regulatory, Quality and regions. Scheduling and management of departmental and cross-functional meetings (e.g. Data Safety Monitoring Board (DSMB), Executive safety review committee meetings). GPS Budget management. GPS Share point management/maintenance. Collaborate with Safety quality and compliance team in the development and implementation of an inspection readiness strategy. Contributes to, drafts and implements department SOPs and work instructions related to the PV activities. Represents GPS as a leader on project teams, other departments, and committees as needed. Qualifications Training in relevant subject, life science degree, and/or Post-graduate specialization in project or business management (e.g. PMP, MBA). Minimum 5-10 years' experience in the pharmaceutical industry, predominately in pharmaceuticals project or program management, having worked on both development and marketed products. Experience in managing pharmacovigilance projects desired. Demonstrated leadership in complex project management with business partners and experience in vendor management. Experience working on a cross functional team and strong project and business management skills. Credible knowledge of global regulations governing Pharmacovigilance in the pharmaceutical industry and Research & Development processes. Strong organizational, planning, prioritizing and problem-solving skills. Effective multi-tasking skills applied in different and complex assignments and ability to work effectively under pressure and under strict timelines. Ability to work both independently and collaboratively and use own initiative. Ability to communicate effectively both locally and globally, internally and externally. Operational expertise in ARGUS preferred. Proficient MS Office skills. Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements. Tolerance for ambiguity and ability to adapt quickly to a changing business environment. Highly resilient, tenacious and resourceful. Occasional travel (up to 20%) for business, meetings and professional development activities. High attention to details. Maintains a positive and professional demeanor toward all customers and coworkers. 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
May 23, 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 Manager, Pharmacovigilance (PV) Operations is a technical expert in Global Patient Safety who establishes and maintains regional PV operations in collaboration with partner organization, local vendors and local marketing authorization holders (MAHs). In this role, the individual will provide technical expertise to the Global Patient Safety (GPS) Operations Team in managing the AveXis local and global Safety System (AGSS) functionality. The Manager will support the Argus Safety system, oversee the hosting vendor and ensure that requests for system issues, enhancements and other system changes are resolved in a timely manner. This individual should be a self-starter with excellent pharmacovigilance knowledge and project management capabilities in pharmacovigilance who is seeking to be part of an innovative and fast-paced team to support the company's drug development activities. Responsibilities Maintains and establishes the global/regional pharmacovigilance (PV) system in collaboration with partner organizations, local marketing authorization holders (MAHs) and Vendors. Primary contact for PV Operations in regions (US, EU, Latin America and Asia Pacific). Owner of the design of processes to meet local PV requirements. Primary liaison between Partner Country Offices and AveXis regional staff for PV. Establishes local PV processes with local MAH and vendors. Works with Manager, Global Safety Operations to incorporate local PV requirements in the global system. Liaise with Global Risk Management scientist to ensure local requirement are incorporated for the risk management plan. Provide back up and overflow support for Manager, global safety operations. Accountable for the day-to-day oversight of the hosting vendor and managing SLAs (service level agreements) to ensure that outstanding tickets are resolved in a timely manner. Manage and track the status of system change requests, enhancements and/or support efforts. Support planning and implementation of safety system enhancements and upgrades in collaboration with the vendor. Work with vendor, Clinical Operations Team and Safety Operations team to troubleshoot E2B reporting issues. Maintains list of reporting algorithms and labelling decisions. Contributes to testing of new system configurations and report design. Serves as resource for inspections and audits, including delivering database queries. Qualifications Bachelor's degree in a Life Sciences discipline, Nursing or Pharmacy. 7-10 years' experience working within the Drug Safety/ Pharmacovigilance domain including pharmacovigilance operations in regions (EU, US, Latin America, Asia Pacific). At least 3 years of pharmacovigilance systems and operations experience. Experience with managing PV database hosting vendor and business partners. Strong knowledge of rules and regulations applicable to the Global Safety industry. Attention to detail, results-oriented and persistent with excellent organizational skills. Self-motivated and ability to work independently in a fast-paced environment, prioritize multiple tasks and recognize time sensitivity. Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing. Strong project management, organizational, planning, prioritizing and problem-solving skills. Ability to work both independently and collaboratively and use own initiative. Ability to communicate effectively both locally and globally, internally and externally. Proficient MS Office skills. Approachable, flexible and self-motivated. Open to changes, suggestions and innovations, continuously on the look-out for work processes improvements. Tolerance for ambiguity and ability to adapt quickly to a changing business environment. Highly resilient, tenacious and resourceful. Occasional travel (up to 10%) for conferences, meetings and professional development activities. 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. 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
May 23, 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. AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team in Durham, NC. The individual will be responsible for sampling of incoming raw materials and performing associated release activities. The QC Analyst is responsible for routine sample testing under GMP mode, laboratory maintenance, and participating in method qualification/verification. A potential candidate should be able to practice proper analytical techniques. The candidate should be able to adhere to all GMP requirements, FDA/EMEA regulations, and have effective interactions/communication with Quality management. The QC Analyst may also support the identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across the site. Responsibilities Perform routine QC testing using the following analytical methods: FTIR Physical testing (pH, appearance, osmolality, conductivity, sub-visible particulates) Participate in method troubleshooting, qualification and validation if needed. Assist in the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems. Write and revise documents such as SOPs, specifications and technical reports. Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs. Qualifications Minimum B.A. or B.S. in Chemistry or related scientific field with 0-2 years of related experience in a GMP quality control laboratory or equivalent experience. Excellent oral and written communication skill 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. Longmont, CO, USA
May 23, 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. This position in Global Engineering Projects (GEP) is responsible for leading and providing project controls in support of the capitol portfolio. The Senior Project Controls Specialist will be responsible for developing project funding documents, assisting in budget, managing purchase requisitions, tracking purchase orders, change management, cost and schedule risk analysis, cashflow analysis, and developing historical cost data for benchmarking purposes. In addition, they will review and analyze engineering and contractor cost estimates, bids, change orders, invoices, labor rates, physical engineering/construction progress (earned value). This position, partnered with finance, will also develop a robust process with guidance documents and templates related to the project controls aspect, to help drive consistency and efficiency. Responsibilities Lead from a GEP perspective the preparation of project funding documents. Lead from a GEP perspective the preparation, review, and management of project estimates. Lead estimate review meetings. Develop WBS and project coding. Reviewing and analyzing engineer/contractor bids, change notices, costs. Develop and manage cashflow. Review, develop and manage engineering/construction cost forecasts for remaining work. Lead the generation and close-out of requisitions, purchase orders, and contracts. Preparing monthly project status reports for Project Managers and leadership (review, analyze, forecast). Lead risk analysis reviews and managing risk model. Drive operational excellence and continuous improvement. Partner with finance to develop tools and templates which will be integrated into the overall project lifecycle. Lead the annual capital planning activities with support from finance in support of the overall P&L timelines. Qualifications Bachelor's degree from accredited institution, or 4 years of equivalent work experience AND A minimum of 10 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in facility build, equipment procurement, capital budget management, and asset lifecycle management. Experience in the construction of biotech or pharmaceutical facilities. Driven individual with a strong focus on problem solving and issue resolution. Systems based thinking to drive consistency and efficiency. Strong technical knowledge in construction cost and schedule management. Strong analytical skills for estimate analysis, bid evaluations, budget monitoring, cashflow analysis, risk analysis and benchmarking project costs. Good understanding of all types of estimating from conceptual through definitive construction estimates. Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Flexibility to travel as needed up to 25%. 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. Libertyville, IL, USA
May 23, 2019
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 Engineer is responsible for assisting with the development and improvement activities for the upstream manufacturing processes used to manufacture AveXis gene therapy products at a site. This individual will support the collection and interpretation of continued process verification data and collaborate with other departments on manufacturing related issues to drive resolution and process improvements. Responsibilities Serve as a scientific and technical representative for upstream 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. 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. Complete requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support. Qualifications Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field. Excellent oral and written communication skills. Preferred Experience 2-5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture. Additional experience in recovery, purification, or aseptic fill/finish is also beneficial Familiar with global regulations on devices, drugs, 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-JH1
AveXis Inc. Libertyville, IL, USA
May 23, 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. This position in Global Engineering Projects (GEP) is responsible for delivering projects in the GEP network in support of the global capitol portfolio. As part of the GEP team, this position will be based in our Libertyville facility, but assignments may be located at other network sites in California, Colorado or North Carolina. This individual shall understand cGMPs and have experience managing projects in a highly regulated pharmaceutical or biotech facility. The Project Manager serves as the primary client contact for assigned projects. The Project Manager is responsible for establishing and maintaining project scope, deliverables, schedules, budgets, reports, and elevating roadblocks. The Project Manager will manage the project team and request resources as required. Responsibilities Manages small to medium projects ($0.5 - 5 M); projects of staff and contractor teams (2-5 people). Ensures all assigned projects are delivered on time and within the budget. Ensures all projects are executed in accordance with Global standards. Manages planning and scheduling conflicts among the project team and with production. Manages client expectations efficiently with minimal guidance. Maintains strong working relationships with all client representatives. Develops project objectives working with user requirement and business plans. Prepares, owns, and maintains project budgets. Communicates issues or risks in a timely and effective manner and develops mitigation plans to address/resolve them. Prepares vendor scopes of work and request for proposals (RFP). Work with suppliers and vendors for projects to review and receive quotes. Ensures all project close-out activities are completed. Identifies and reports on lessons learned after the project close-out. Provides technical leadership for multiple engineering projects simultaneously. Drives operational excellence and continuous improvement. Qualifications Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience AND A minimum of 5 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in facility build, equipment procurement, capital budget management, and asset lifecycle management. Experience with cGMP construction for brownfield and facility renovations. In-depth knowledge of FDA regulations and GMP systems. Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. 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. Libertyville, IL, USA
May 23, 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. This position in Global Engineering Projects (GEP) is responsible for providing project engineering in support of the capitol portfolio. As part of the GEP team, this position will be based in our Libertyville facility, but assignments may be located at other network sites in California, Colorado or North Carolina. This individual shall have a strong understanding of cGMP's and experience providing engineering service and oversight in a highly regulated or pharmaceutical / biotech facility. Individual will participate or lead the design, implementation and testing of facilities (retrofits or expansions) and equipment (both process and utility) projects. The ideal candidate will be able to function independently as the technical lead for small to medium scale projects and as part of a team depending on large projects. The individual will be able to provide technical expertise from initial concept through detail design, installation, system commissioning, and startup. Responsibilities Responsible for providing technical leadership for multiple engineering projects simultaneously Be the technical lead on each specific project for design, analysis and layouts of buildings, equipment, state regulations, federal regulations, manufacturing efficiency and managing contractors (architects, HVAC, Service Engineers etc.) Generate Scopes of Work for outsourced services Partner with design engineering companies to develop detailed plans, specifications, and drawings as biddable packages Partner with construction companies and lead the field execution and installation of facilities, utilities and equipment Develops project objectives working with user requirement and business plans Determines project specifications and cost-effective technology's to be implemented Establish equipment and facility specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS) Participates in all testing efforts (FAT, SAT, IV, OV) Review and approve critical documentation such as SOP's and URS's Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies Help to develop and maintain project budgets Problem solve technical issues during startup and commissioning Prepare contingency plans and logically work through complex issues Effectively manages 3rd party engineering partners in the installation, commissioning, and start-up of capital projects Work with suppliers and vendors for projects to review and receive quotes Apply lean thinking to engineering office processes Drive operational excellence and continuous improvement Qualifications Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience AND A minimum of 7 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in facility build, equipment procurement, capital budget management, and asset lifecycle management Experience in the development, automation, and manufacture of gene therapy products, biotech or pharmaceutical products, medical devices, instruments, or biotechnology Experience in process layouts, production layouts and capital improvement projects In-depth knowledge of FDA regulations and GMP systems Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products Excellent oral and written communication skills. Strong technical writing ability required 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. Libertyville, IL, USA
May 23, 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. This position in Global Engineering Projects (GEP) is responsible for managing the engineering drawings and drawing standards. As part of the GEP team, this position can be based in our Libertyville, Illinois; Durham, North Carolina; San Diego, California; or Longmont, Colorado facilities. Responsibilities Provide drawing administration, support, training and mentoring. Manage the SharePoint drawing requests site. Review and approve drawing change requests and track them to completion. Self-perform or assign drawing update to drafters. Liaise with A&E firms to ensure audience to AveXis drawing standards. Manage the strategic direction and development of procedures to ensure efficiency of project drawings. Manage designers by establishing initial design specifications. Develop, implement and monitor drawing design standards to meet company needs. Research and analyze new and emerging CAD technologies and software to keep department up to date. Drive operational excellence and continuous improvement. Qualifications Bachelor's degree from accredited institution, or 4 years of equivalent work experience AND A minimum of 4 years of experience managing cooperate drawings in a pharmaceutical or biopharmaceutical based GMP manufacturing operations. Proven management skills. Must be analytical, organized and detail-oriented with a strong knowledge of DRAWING design flows. Experience with 3D CAD modeling. Excellent oral and written communication skills. Strong technical writing ability 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. San Diego, CA, USA
May 23, 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. Responsible for developing a system to compile, analyze, illustrate, and distribute technical process performance data in support of the Technical Development/MSAT organization, with emphasis on the upstream and downstream processes as well as analytical methods. The role will also be expected to collaborate with site MSAT teams to evaluate cross-site performance (internal and external) and contribute to data analysis and reports to support approval of, AveXis gene therapy products. This individual must have foundational knowledge of upstream, downstream, and analytical areas to support the broader team and be able to highlight relevant data through review. The role will provide leadership and support for process, analytical, and characterization knowledge related to the production of AveXis gene therapy products. Responsibilities of primary importance are to compile, monitor, review, and output data to advance the development of AveXis products from research to development to GMP manufacturing. The successful candidate will take responsibility to ensure all documentation and reports are accurate, complete, and suitable for use in support of production, characterization, and regulatory approval. Responsibilities Provide scientific and technical input for process-related issues at internal AveXis sites, as well as with external partners. Perform trending and monitoring of critical quality attributes/process parameters to maintain product quality and to control process drift. Monitor cross-site manufacturing process performance to identify key areas of risk and development based on process performance data in the commercial, clinical, and development spaces. Perform statistical analyses to understand normal process variability, support establishment of parameters and criteria, and process comparability assessments. Identify potential process improvements in conjunction with the process owner teams and manufacturing operations. Assist in documenting changes/updates to manufacturing processes and work with manufacturing, engineering and validation to implement those changes. Review and provide feedback and technical/scientific support on project deliverables (e.g. remediation initiatives, plan reports). Assist in manufacturing by supporting investigations in partnerships with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective. Participate in the collection and interpretation of data and collaborate with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals. Qualifications Minimum B.S. degree in analytical chemistry, biochemistry, chemical engineering, bio-engineering, or related technical field; Master's degree or PhD preferred. Expertise with a variety of data collection systems, analysis tools, and development of Excel macros. 4-10 years of experience in bio pharmaceutical based GMP manufacturing operations including direct experience in either fermentation, recovery, purification, or analytical methods development. Familiar with global GMP regulations. Excellent communication skills and attention to details. Strong organizational skills and ability to multitask across projects and activities. Proven ability to effectively lead and participate on teams. Approximately 10% 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-JH1
AveXis Inc. Libertyville, IL, USA
May 23, 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 Associate Director, Global Packaging Technology is responsible for end-to-end packaging supply chain activities for Commercial and Clinical supply. They will be accountable for design, development, and qualification of secondary and tertiary packaging systems, driving simplification and supply optimization in response to all business drivers. The individual is chartered with enabling packaging supply chain security and the brand protection strategy and road map. This individual will play a key role within Global Supply Chain, assisting with vision setting and development of new packaging technology capability. Responsibilities Design, develop, and qualify secondary and tertiary Clinical and Commercial product packaging (i.e. cold chain bulk and finish goods) focused on identifying opportunities to optimize cost, service and quality (i.e. print-on-line technology to leverage Late Stage Packaging supply). Establishes Clinical and Commercial packaging supply chain systems and processes based upon key business drivers: compliance and risk management, process rationalization, supply performance, etc. Actively supports root cause analysis for Clinical and Commercial packaging related quality investigations Collaborate with MS&T with primary pack design and selection ensuring supply robustness. Lead artwork labeling design and development for Clinical programs and supply. Actively supports technical impact assessments for secondary and tertiary packaging systems. Establishes packaging supply chain security and brand protection strategy and road map Partners with regional Supply Chain leads to understand current and proposed packaging related market requirements and how to best influence and advocate for robust supply solutions (i.e. Serialization, Child Resistance, Tamper Evidence). Build strong cross-functional relationships and provide global packaging technology leadership and vision for ensuring robust, effective, and efficient Clinical and Commercial supply. Qualifications Bachelor's degree in Business or technical field and Master of Business Administration (MBA). Minimum of 7 years of experience in pharmaceutical and biotech Clinical and Commercial packaging supply chain systems. Business acumen - knows how to assess market/business requirements and develop appropriate business case justifications that ensure compliance and/or improve supply. Experience working in highly regulated industries. Experience in a continuous improvement environment with a track record of achieving results. Demonstrated collaborative style in performing sourcing activities. Influences without authority to motivate and manage a cross-functional team in multiple geographies. Hands-on manufacturing and/or supply chain 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-JH1
AveXis Inc. Libertyville, IL, USA
May 22, 2019
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 Quality Control (QC) Group is part of the Quality organization and is responsible for testing of raw materials, in-process, release, and stability samples. The Planner will be primarily responsible for coordinating, developing, and managing QC schedules on a daily basis with real time updates of routine and non-routine activities to increase efficiency and productivity. Additionally, the Planner will be responsible to develop effective scheduling process to achieve testing objectives. The successful candidate will work in a cGLP environment and must have working knowledge of a QC environment, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded. Skills in statistics required to effectively analyze trends is also desired. Responsibilities Coordinate, develop, and manage QC schedules daily with ability for real time updates of routine and non-routine activities to increase efficiency and productivity. Develop effective scheduling process to achieve testing objectives. Analyze and address testing issues related to scheduling in real time. Oversee routine equipment maintenances to avoid outages and repairs during testing. Manage testing schedule to accommodate maintenance activities and non-routine requests. Organize job trainings for staff to meet testing goals and objectives. Update testing training materials. Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. Support strategic proposals, progress updates and presentations to all levels of the site organization. Qualifications Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience. Prior experience scheduling testing in a GLP environment is required. Experience with scheduling tools that could be used for real time updates to a testing schedule is required. Experience in laboratory bench work strongly desired. Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting. Must be proactive, action oriented, and have the ability to adapt to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track. Must have strong communication skills both verbally and written. Must have proven logic and decision-making abilities, critical thinking skills. Must be able to accommodate testing schedule as required. Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills. Six Sigma Yellow, Green or Black Belt certification is preferred. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1