• Director, Quality Assurance, External Manufacturing

    Job Locations US-IL-Libertyville
    Posted Date 1 week ago(4/10/2019 12:37 PM)
    Job ID
    2019-3278
    # of Openings
    1
    Category
    Quality
  • 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 QA External Manufacturing (CMO) is responsible for quality assurance oversight of all CMO activities, including providing quality leadership for Tech Transfers between AveXis sites and CMOs.  This position is also responsible for scaling up the existing team to a highly talented group of individuals to support the growing business needs while driving risk management and continuous improvement activities.

    Responsibilities

    • Develop and deliver robust procedures and processes for efficient quality oversight of CMO operations for clinical trial and commercial product supply.
    • Act as a critical thought leader for GMP operations and workflows pertaining to CMOs, AveXis Internal QC and External Contract Test Laboratories.
    • Create risk based, compliance and business aligned strategies for phase appropriate batch release operations.
    • Act as Quality Lead for activities relating to the tech transfers.
    • Provide routine updates to Senior Management, including escalation of issues.
    • Recruit and manage a high performing, collaborative team of External QA operations professionals to support quality operation activities including:
      • In collaboration with the Quality Systems teams at CMO and AveXis, ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause.
      • Materials Control and Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for disposables, starting materials, packaging materials, intermediates, bulk and finished product.
      • Oversight and approval of QC (External and AveXis Site) related activities: EM, release data, stability, sterile operations review.

    Qualifications

    • Minimum B.S. degree, preferably in microbiology, chemistry or biochemistry.
    • 10-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product preferred. Experience with viral gene therapies and/or orphan disease indications is a plus.
    • Minimum 3 years’ experience in an External Manufacturing/CMO compliance management role.
    • 7+ years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff.
    • Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
    • Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product/facility related investigations and deviations.
    • Excellent oral and written communication skills with strong technical writing experience required.
    • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
    • Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
    • Strong knowledge and application of the CFRs and cGMPs and have been involved in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international).
    • Domestic and international travel required (25%).

     

    This position will be located out of our Chicago (IL) or RTP (NC) office.

     

    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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