• Senior Manager Facilities

    Job Locations US-NC-Durham
    Posted Date 4 weeks ago(6/19/2018 4:02 PM)
    Job ID
    2018-1278
    # of Openings
    1
    Category
    Manufacturing
  • 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.

     

    AveXis is seeking a Senior Facilities Manager to lead a team responsible for overall facility maintenance and calibration activities including lab equipment, manufacturing process equipment and utility systems. This position plans, budgets, schedules, and drives overall facility and maintenance activities including small capital projects and operational activities

    Responsibilities

    • Manages and supervises the activities of the Facilities Maintenance staff and third-party vendors to maintain a reliable, secure and compliant site.
    • Provides Facilities support to manufacturing and laboratory activities.
    • Provides input on capital projects to upgrade or expand facilities and equipment needed. Assists in planning, execution and documentation.
    • Helps ensure compliance of the site with a specific focus on Facilities and Maintenance operations relative to applicable US and international regulatory agencies including OSHA and FDA.
    • Manages staff and coordinates Facility shutdowns to ensure maintenance and calibration activities are completed in a timely manner, including all necessary documentation.
    • Ensures that department resources are available to promptly respond to and resolve Facility and Maintenance problems as needed at all times.
    • Manages third party service provider relationships; maintains a master contact list and ensures that appropriate service agreements are in place and vendors are appropriately trained and qualified.
    • Supports timely closure of facility related cGMP deficiencies including audit observations, corrective and preventative actions (CAPA) and deviations.
    • Assists in establishing KPI’s including staying within the budget, and ensures staff support and meet KPI’s. Takes corrective actions to mitigate performance gaps.

    Qualifications

    • BS degree in engineering or related field or equivalent experience required.
    • At least 10+ years of facility infrastructure & operations management for GMP production in biotech/biopharma industry.
    • Demonstrated ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace, dynamic team setting.
    • Strong interpersonal, verbal and written communication skills are essential.
    • Advanced degree such as an MBA would be an advantage
    • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
    • Ability to adapt in a constantly evolving environment
    • Self-motivated with a strong sense of ownership in areas of responsibility

    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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