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Senior Manager, Manufacturing Science and Technology

Company: AveXis Inc.
Location: Longmont
Posted on: June 16, 2019

Job Description:

OverviewReady to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior Manager is responsible for defining the technology transfer strategy for the processes used to manufacture AveXis gene therapy products at the site and contract manufacturing sites. Working with Quality, Engineering and Manufacturing, this individual will develop program level procedures for process tech transfer of Avexis products globally. This will include leading the development of tech transfer plans, protocols and reports for commercial and clinical products at the site and contract manufacturers. In addition, this individual will be the technical lead for process tech transfers to the site and contract manufacturing sites.Responsibilities

  • Development of site and/or global procedures to govern process tech transfers of gene therapy products.
  • Serving as a scientific and technical lead for tech transfer related issues and investigations at the site of manufacture.
  • Partnering with Quality, Engineering and Manufacturing to ensure robust process tech transfer plans, protocols and reports.
  • Mentor and train other team members.
  • Provide technical leadership as required during start-up efforts of new processes within manufacturing.
  • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and Quality to implement those changes.
  • Provide technical leadership for the transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
  • Identify opportunities to implement operational excellence and continuous improvement.
  • Build strong relationships with Quality to ensure a compliant manufacturing environment.
  • Provide process expertise during health authority inspections of AveXis products at the site.
  • Provide technical process expertise to external manufacturers.
  • Assist the external manufacturing team to resolve any issues related to production issues at 3 rd party manufacturers.
  • Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support. Qualifications
    • M.S. degree in biochemistry, chemical engineering, bioengineering, or related scientific field and at least 10 years of experience in support of biopharmaceutical manufacturing OR
    • B.S. degree in biochemistry, chemical engineering, bioengineering, or related scientific field and at least 12 years of experience in support of biopharmaceutical manufacturing
    • Excellent oral and written communication skills.
    • Experience in senior technical roles within a biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish.
    • Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
    • Strong technical writing ability.
    • Proven ability to effectively lead and participate on teams.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

Keywords: AveXis Inc., Denver , Senior Manager, Manufacturing Science and Technology, Executive , Longmont, Colorado

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