• Manager, Quality Control Analytical Projects

    Job Locations US-IL-Libertyville
    Posted Date 7 days ago(8/8/2018 3:28 PM)
    Job ID
    2018-2434
    # 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. 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, Quality Control Analytical Projects will support the design and development of tests, studies, procedures, and specifications for the AveXis pre-clinical and clinical material programs. This includes cGMP release and characterization testing using analytical techniques such as PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC-ELSD, HPLC-MS), spectrophotometry, AUC, and electrophoresis (CE, PAGE, western blotting). This position will be the analytical subject matter expert (SME) for external analytical projects. 

    Responsibilities

    • Oversee and collaborate with contract testing labs and contract manufacturing organizations.
    • Lead the development, qualification, validation, and transfer of analytical methods.
    • Interpret characterization, product release, and stability data.
    • Participate in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions.
    • Work closely with the regulatory team to provide analytical documentation to the FDA and international regulatory agencies during regulatory submissions.
    • Act as the subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
    • Author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA).
    • Perform other related duties as assigned.

    Qualifications

    • Bachelor's Degree in Chemistry, Biology or related sciences.
    • Minimum 8 years of relevant experience in pharmaceutical testing laboratory.
    • Strong working knowledge of protein chemistry and analytical test methodologies: Immunoassays, PCR, chromatography, and electrophoresis.
    • Prior experience with method development of biologics, QC, stability, IND submissions, BLA or NDA submissions is important for success in the position.
    • Understanding of applicable USP, ICH, and Ph Eur regulations as they relate to QC testing is also highly desirable.
    • Expertise in use of Excel or comparable software solutions for management and analysis of data.
    • Outstanding problem-solving abilities.
    • Ability to work independently and effectively.
    • Ability to prioritize and deliver on tight timelines.
    • Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building.
    • Good critical thinking, deductive reasoning, and decision-making skills.
    • Approximately 25% travel required.

    This position will be based out of our Manufacturing sites located in Libertyville, IL or Durham, NC.

     

    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. 

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