• Manager, Manufacturing Support (Deviation/CAPA Management)

    Job Locations US-NC-Durham
    Posted Date 2 weeks ago(2/2/2019 8:22 AM)
    Job ID
    2019-2963
    # of Openings
    1
    Category
    Manufacturing
  • 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 Manager Manufacturing Support – Deviation/CAPA Management is responsible for providing required support to the engineering, validation, MSAT, maintenance, QC and QA groups. This role will be responsible for investigating complex deviations and supporting the applicable CAPA’s discovered in the upstream, downstream, fill/finish, or manufacturing support groups.  This individual will ensure our programs and manufacturing are in a state of control and all non-conformances are managed within the given timelines.

    Responsibilities

    • Provide Complex Deviation/CAPA support for the manufacturing process owners/groups.
    • Facilitate site Deviation/CAPA forum and ensure process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at multiple production sites.
    • Follow up with Deviation/CAPA owners to make sure all new Deviations/CAPA’s are completed on time. Track KPI's tied to deviation management and provide updates to department management monthly.
    • Serve as a lead investigator/mentor for complex deviations, escalate issues as required to site leadership team.
    • Supervise Deviation/CAPA specialists by providing work direction, performance management and professional development.
    • Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Requires direct input on the creation and effectiveness of Corrective and Preventive Action plans. Assist with implementation and supporting on-going continuous improvements.
    • Identify, develop and implement process robustness improvements through lean principals.
    • Support internal and external audits for complex deviations.
    • Support the PMO group for any technology transfer activities.
    • Support site change controls as needed.
    • Responsible for maintaining quality standards to meet GMP requirements, CFR’s and internal company policies with respect to the Deviation/CAPA process.

    Qualifications

    • Minimum B.S. degree in Engineering or the life sciences and 8 years of work experience in biopharmaceutical based GMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools.
    • In-depth knowledge of FDA regulations and GMP systems and experience interacting with various regulatory agencies in a highly regulated or pharmaceutical / biotech facility.
    • Applied knowledge of quality by design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
    • Excellent oral and written communication skills. Strong technical writing ability required.
    • Travel as required to other internal sites, vendors, and CMOs as required (~10%).

    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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