• Project Manager, CMC Regulatory

    Job Locations US-IL-Libertyville
    Posted Date 4 weeks ago(6/1/2019 5:12 PM)
    Job ID
    2019-3299
    # of Openings
    1
    Category
    Regulatory
  • Overview

    Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis 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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