• Manager, Health and Safety

    Job Locations US-NC-Durham
    Posted Date 1 month ago(12/21/2018 7:04 AM)
    Job ID
    2018-2690
    # of Openings
    1
    Category
    Manufacturing
  • 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. 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.

     

    AveXis is seeking a Manager, Health and Safety to assist in the adherence to all Federal, State and Local requirements, as well as AveXis policies, strategies, initiatives and goals. This role will provide expert support to internal staff in anticipating, recognizing, evaluating, and controlling biosafety, chemical, and physical hazards. This position will serve as the Biological Safety Officer for the site providing technical direction and consultation for Biosafety Program-specific elements. The programs managed by this position may include but are not limited to:  Biological Safety; Hazard Communication; Chemical Hygiene; Lockout/Tagout; Electrical Safety; Emergency Response; OSHA Recording-keeping; Incident/Illness tracking and trending, etc. This role will participate on multi-disciplinary teams that conduct work activity reviews, safety & health inspections, incident/near miss investigations, special projects, and assist with external regulatory agency inspections/communications. The Manager will join a site committed to EHS excellence and be an integral contributor to building a culture where all colleagues play an integral role in EHS success.

    Responsibilities

    • Assist in the development, implementation and administration of AveXis' overall Health and Safety policies and procedures.
    • Provide technical information and specialized training related to safety and health risks covered under OSHA regulations and/or other applicable laws and safe work practices.
    • Serve as a subject matter expert for matters related to Biosafety and overall implementation of Biosafety program requirements.
    • Conduct risk assessments of biological, chemical, and physical hazards in the workplace and partner with stakeholders to ensure robust controls are in place.
    • Participate in formal reviews of existing equipment modifications, new equipment purchases, and changes in site processes to assess potential safety and health impacts.
    • Participate in audits for compliance with applicable health and safety programs and policies and participate in the development of Corrective and Preventative Actions (CAPAs).
    • Establish and lead the site’s Safety Committee.
    • Prepare and/or assist with tracking, trending and communicating incidents; monthly metrics; and audit reports.
    • Review safety and health regulations and update policies and procedures as directed.
    • Training development and execution.
    • Lead and participate on site’s emergency response team.
    • Lead and participate in inspections and audits.

    Qualifications

    • Bachelor’s Degree in Industrial Hygiene, Occupational Safety, Science, Engineering, or related field required. An advanced graduate degree in an area closely associated with Biosafety is desired.
    • Professional EHS certification (e.g. CSP, CIH) and Biological Safety Professional credentials (e.g., RBP, CBSP) or the desire to attain them is strongly preferred.
    • 10+ years of health and safety experience in a manufacturing environment required with prior biopharmaceutical industry experience desired.
    • Ability to apply knowledge of NIH, OSHA, ANSI and other pertinent federal, state, and local regulations, standards, and guidelines.
    • A broad knowledge of and proven ability to apply biosafety and EHS principles to enable creative solutions to complex opportunities and mechanisms for measuring results.
    • Excellent interpersonal, written, and verbal communication skills with the ability to effectively interface with internal and external stakeholders to achieve required outcomes.
    • Ability to plan, prioritize, and perform multiple tasks with high quality as part of a high-paced work environment.
    • Ability to cultivate employee commitment to a high-performing EHS culture.

     

    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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