Manufacturing Manager - Gene Therapy Production

Avexis Durham , NC 27701

Posted 2 months ago

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. 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 Manager of Manufacturing (multiple positions) that will be responsible for organizing, managing, and continuously improving the manufacturing operations and process at the AveXis manufacturing site. This individual will be directly responsible for a team of BioProcess Engineers whose direct responsibilities include producing product on the manufacturing floor. The manufacturing manager will be the first line of contact to handle process and equipment deviations on the floor. Areas of responsibility could include both upstream (cell culture), downstream (Purification), and fill/finish activities.

Responsibilities

  • Produce clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations.

  • Schedule daily operations (finite scheduling) for manufacturing and cleaning processes. Ensure manpower resources are adequate to complete operations.

  • Lead investigations as related to the manufacturing process. Author deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.

  • Ensure documentation (batch records and SOPs) are accurate and updated as required.

  • Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.

  • Provide monthly manufacturing metrics as determined by management.

  • Lead areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects.

  • Identify and implement continuous improvement opportunities.

  • Lead and mentor staff. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.

Qualifications

  • Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.

  • A minimum of 8-10 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification (TFF, chromatography), aseptic fill/finish with:

  • Solid knowledge of FDA regulations and GMP systems.

  • Excellent oral and written communication skills. Strong technical writing ability required.

  • Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence. Demonstrated leadership skills.

  • Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.

  • Experience with viral manufacturing and transfection a plus.

  • NOTE: This role will require the ability to travel extensively for the 1st 9-18 months of employment.

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.


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Manufacturing Manager - Gene Therapy Production

Avexis