• Senior Manager of QA, External Manufacturing

    Job Locations US-IL-Libertyville
    Posted Date 2 months ago(4/6/2018 11:20 AM)
    Job ID
    2018-1178
    # of Openings
    1
    Category
    Quality
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting 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 at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    Position Summary

    AveXis, Inc. 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 Sr. Manager, QA, External Manufacturing (CMO) is responsible for quality assurance oversight of all CMO activities, including reviewing Batch Master Records, Manufacturing Plans and documentation for the disposition of GMP materials (batch record review, deviations, change controls, tech transfers, and validations).  The Sr. Manager, QA, External Manufacturing (CMO) is also responsible for specifications for raw materials and consumables in order to ensure consistency across manufacturing sites.

    Responsibilities

    • Supports third party operations for clinical trial and commercial manufacturing supply
    • Works across multiple functions to assure the supply of quality products to patients through the review of batch record documentation and investigates issues including customer and vendor complaints
    • Supports the transition of activities relating to the tech transfer of products
    • Escalates issues / challenges as needed to manager
    • Other duties as assigned

     

    Qualifications

    • Bachelor’s degree required in Chemistry, Biochemistry or similar technical disciplines
    • Minimum 7 years’ experience in a QA role working in a pharmaceutical environment with knowledge of cGXP and quality management systems
    • Minimum 5 years’ experience in managing complex projects
    • Minimum 3 years’ experience in QA support of manufacturing of recombinant proteins or plasmid DNA
    • Minimum 3 years’ experience in an External Manufacturing/CMO compliance role
    • High level of accuracy and attention to detail
    • Good written and verbal communication skills with the ability to convey information clearly and accurately
    • Knowledge of clinical trials and commercial manufacturing
    • Experience managing customer complaints
    • Good problem solving skills
    • Travel Requirements: Domestic and international travel required (25%)

     

    This position will be located out of our Chicago area 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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