• Director, Engineering

    Job Locations US-IL-Libertyville | US-NC-Durham
    Posted Date 7 days ago(6/11/2018 3:42 PM)
    Job ID
    2018-1292
    # of Openings
    1
    Category
    Engineering/Validations/BioProcess
  • 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.

      

    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, 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 Director, Engineering will have oversight for Process Engineering, Facilities and Maintenance, along with Validation functions. This role will have responsibility for lifecycle management of the facility, utilities and process equipment from commissioning and qualification through normal lifecycle including the site Validation Master Plan (VMP). The role also has responsibility to manage or support site driven capital engineering projects along with engineering resources in support of site plan activities.

    Responsibilities

    • Develop, implement and own comprehensive engineering, maintenance and facility strategy for the site, and the supporting policies and procedures.
    • Actively influence and participate in the site leadership team and establishing effective cross-functional leadership relationships and presence.
    • Drive implementation of engineering and facility capital projects within budget and timeline and implement new biologic process technologies.
    • Manage project teams consisting of FTE and contract resources.
    • Deliver a site Validation Master Plan and maintain all relevant equipment in validated state.

    Qualifications

    • Bachelor of Science in Engineering, Chemical Engineering, Biochemistry or equivalent.
    • A minimum of 8-10 years’ experience in biopharmaceutical based GMP manufacturing operations and methods including direct experience in validation, automation, and manufacturing related systems and technologies including: Strong knowledge of validation requirements for gene therapy manufacturing facilities, equipment and processes.
    • Previous experience with new manufacturing technology and modular concept design.
    • 5+ years of direct supervisory experience of technical professionals with demonstrated effectiveness in providing guidance, mentorship, and support to staff.
    • Knowledge and understanding of cGMPs, CFRs and ICH 08, 09, and 010.

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed