• Senior Manager, Program Management and Strategy

    Job Locations US-IL-Libertyville
    Posted Date 2 days ago(4/16/2019 10:25 AM)
    Job ID
    2019-3315
    # of Openings
    1
    Category
    Project Management
  • 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.

     

    This person is responsible for driving project management activities supporting process development as well as clinical and commercial supply. This includes managing projects cross-functionally as well as through critical external development partnerships.  The successful candidate will be responsible for managing project timelines and budgets, as well as facilitating effective cross-functional communication and information transfer to and from our commercial manufacturing sites. This person will be responsible for communicating project status, issues, assessing risks, and proposing solutions to the team.

    Responsibilities

    • Management of timelines and deliverables of tech transfer, process development, and other complex projects executed at CMOs and development partners.
    • Provide management with weekly/monthly metrics and progress dashboards reflecting status of all development and manufacturing activities.
    • Highlight and escalate issues along with mitigation options/solutions.
    • Other project timelines and tracking as required (CMC/IND/BLA).

    Qualifications

    • Minimum B.S. degree in science related field; higher level degree: MS, MBA preferred but not required, PMP Certification preferred but not required.
    • Minimum 5 years of experience in cGMP environment handling complex projects.
    • Direct, hands-on experience in manufacturing, quality, and contract supplier/customer interactions.
    • Strong project management, budget, and presentation skills.
    • Ability to synthesize detailed information and provide critical insights across manufacturing and supply chain.
    • Experience working with contract suppliers and customers (ability to build strong relationships and influence positive results).
    • Knowledge and understanding of cGMPs.
    • Highly skilled in using project management tools, including but not limited to: Microsoft Project, Microsoft Excel, Microsoft PowerPoint, SmartSheets, ThinkCell.

    This position will be located out of our Libertyville, IL office, with 25% travel.

     

    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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