• Project Manager, CMC Regulatory (Multiple Openings)

    Job Locations US-IL-Libertyville
    Posted Date 3 days ago(4/15/2019 8:49 PM)
    Job ID
    2019-3299
    # of Openings
    1
    Category
    Regulatory
  • 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 Project Manager is responsible for project management activities supporting manufacturing and supply chain deliverables interfacing with CMC Regulatory, Quality and R&D teams. This person will be instrumental in coordinating the completion of CMC regulatory documents to support Global Regulatory Authority filing requirements and ensure the manufacturing and development teams are prepared for regulatory authority meetings, IND, BLA and CTA filing.

     

    This includes managing projects cross-functionally with key consultants and subject matter experts. This person will also manage critical projects interfacing directly with manufacturing science and technology (MS&T) and supply chain to monitor projects supporting licensure and product launch. The successful candidate will be responsible for managing project timelines, as well as facilitating effective communication and information transfer internally and externally.

    Responsibilities

    • Management of manufacturing and supply chain deliverable timelines to support regulatory meetings, filings (IND/BLA/CTA) and commitments.
    • Manage regulatory filing timelines and commitment tracking as required (IND/BLA/CTA).
    • Manage additional manufacturing and supply chain projects supporting licensure and product launch.
    • Responsible for communicating status of all project deliverables.
    • Highlight and escalate issues and risks along with mitigation options and solutions.

    Qualifications

    • Minimum B.S. degree in science related field; higher level degree: MS, MBA preferred but not required, PMP Certification preferred but not required.
    • Direct, hands-on experience in biologics, manufacturing, quality, and CMC regulatory; direct experience with regulatory filings is preferred.
    • Strong project management and presentation skills.
    • Ability to synthesize detailed information and provide critical insights across manufacturing and supply chain.

    This position will be located out of our Chicago (Libertyville) 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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