• EHS- Safety and Health Specialist (GMP)

    Job Locations US-IL-Libertyville
    Posted Date 4 weeks ago(10/20/2018 12:05 PM)
    Job ID
    2018-2483
    # 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.

     

    Assist in the adherence to all Federal, State and Local requirements and AveXis policies, strategies, initiatives and goals. The programs supervised by this position may include but are not limited to:  Hazard communication; Lockout/Tagout; Electrical Safety; Emergency Response; OSHA Recording-keeping; incident tracking and trending. etc. This position assists in assessing, developing and managing key safety and health risks which impact site operations.  In addition, provides technical guidance and support to the site where applicable to maintain compliance with federal, state and local regulations and will assist in external regulatory agency inspections/communications.

    Responsibilities

    • Assist in the development, implementation and administration of AveXis' overall, Health & 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; safe work practices.
    • Assist the site in managing activities that impact areas of health and safety regulatory compliance with federal, state and local regulations.
    • 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).
    • Provide support to 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.
    • Participate on site’s emergency response team.
    • Lead and participate in inspections and audits.

    Qualifications

    • Degree in Occupational EHS discipline is required, Science or Engineering preferred.
    • Professional EHS certification or the desire to attain certification (CSP) is strongly preferred.
    • 3+ years of health and safety experience in a manufacturing environment required.
    • Functional knowledge in regulatory requirements, technical aspects training, auditing / program review, regulatory agency enforcement.
    • Strong communication skills, as well as excellent interpersonal and influence management skills.
    • Incumbent must be able to prioritize and perform multiple tasks without losing momentum.
    • Cultivate employee commitment to a high-performance culture.
    • Actively participate in site Safety Audits.

     

    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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