Manufacturing Quality Specialist (Gene Therapy)

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The successful candidate will be responsible for the Quality oversight of manufacturing operations on the floor and working in collaboration with AveXis staff. The Manufacturing Quality Specialist is responsible for supporting the design, implementation, and continuous improvement of robust Quality Systems for a new viral gene therapy manufacturing site and quality on the manufacturing floor. The MQA Specialist will use risk based decision making to address any issues on the manufacturing floor and will serve as the quality point of contact for the operations. Will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. Will Contribute to the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics; reporting to management all necessary information from plant floor.

The Manufacturing Quality Specialist position is for: Rotational 12 hour shift (2-2-3 schedule) - approximately 6:15 a.m. to 6:30 p.m.

Responsibilities

• Work effectively with Manufacturing Operations, Maintenance, and Engineering on the production floor in making on the spot, risk based decisions; escalate issues to management as necessary.
• Real time on the floor Batch record and logbook review.
• Support and review of SOPs/Documents: documentation, SOPs, instruction sets, specifications, batch record closure, etc. and other Quality procedures directly related to operations and other cGMP activities.
• Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause.
• Non-conformance/CAPA approval and authorship (minor and major investigations).
• Complete on the floor quality audits during the manufacturing processes.
• Independently lead projects to address quality gaps or drive continuous improvement related to Operations or Quality Systems.
• Develop standard work to implement risk based quality oversight program for Operations and ensure routine activities are completed within established timelines.
• Disposition of incoming raw materials for use in production.

Qualifications

• Ability to work the shift schedule of the posted position and lift approximately 25 lbs.
• Willing and able to work other shifts (day, night, and/or weekend) as required in the event of training, projects, short-term coverage, and other circumstances.
• Self-starter with a strong understanding of GMP requirements, acute attention to detail, and ability to assess risk to product quality and compliance.
• Excellent oral and written communication skills with strong technical writing experience required. Capable of providing guidance, coaching, and training Operations and fellow QA personnel to drive continuous improvement and upskilling.
• A minimum of 5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification or aseptic fill/finish.
• Minimum B.S. degree in preferably engineering, microbiology, chemistry or biochemistry or 5 years equivalent industry experience.
• Strong knowledge of and application of the CFR's and cGMP's.
• Direct experience writing or approving major investigation reports with potential product quality impact.
• Able to apply multiple root cause analysis tools.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Experience supporting internal and/or regulatory audits (both FDA and international agencies).
• Lean manufacturing / six sigma experience is a plus.
• Experience with material disposition is a plus.
• Experience with clinical manufacturing, viral gene therapies and/or orphan disease indications is a plus.

The Manufacturing Quality Specialist position is for: Rotational 12 hour shift (2-2-3 schedule) - approximately 6:15 a.m. to 6:30 p.m.

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.

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