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Director, Technical Development --- Downstream Process Owner

Company: AveXis Inc.
Location: Durham
Posted on: May 22, 2019

Job Description:

OverviewReady 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 Director to lead the development and improvement of the downstream manufacturing platform processes used to manufacture, as well as the data and reports to support approval of, AveXis gene therapy products. This individual will define and direct the activity with internal and external organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. The Director will own and manage the process, analytical, and characterization knowledge related to the production of AveXis gene therapy products, and the raw materials need to make them.Responsibilities of primary importance include ensuring the execution of time-sensitive experiments, studies, and validation at external partners while capturing related data and knowledge, to advance the development of AveXis products from Research to Development, and on to GMP manufacturing. The Director will be responsible for owning the upstream portion of the platform processes, planning to avoid delays, and leading the activity to deliver a robust and effective product and manufacturing process. Responsibilities

  • Serving as a key scientific and technical representative for process-related issues at internal AveXis sites, as well as with external partners.
  • Partnering with Clinical and Commercial to assure product design supports safe and effective delivery to patients.
  • Partnering with Manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
  • Partnering with Regulatory to support submissions and approval of product applications.
  • Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Identifying and implementing potential process improvements in conjunction with manufacturing operations.
  • Participating in start-up efforts of new equipment, software or processes in manufacturing.
  • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
  • Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
  • Establishing small-scale production processes and using scaled-down lab processes to enable process troubleshooting.
  • Lead investigations in partnership 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 collaboration with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals.
  • Ensure all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory approval of AveXis products. Qualifications
    • Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field.
    • Master's degree of PhD preferred.
    • Excellent oral and written communication skills.
    • 15-30 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish.
    • Familiar with global regulations on devices, drugs, validation/qualification requirements.
    • Excellent communication skills and attention to details.
    • Strong organizational skills and ability to multi task across projects and activities.
    • Proven ability to effectively lead and participate on teams.
    • Minimum 10 years leadership experience.Approximately 20% to 50% travel may be required.The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-GK1

Keywords: AveXis Inc., Cary , Director, Technical Development --- Downstream Process Owner, IT / Software / Systems , Durham, North Carolina

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