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.
This position is responsible for establishing and implementing environmental, safety, occupational health and threat management policies/programs to ensure there is adequate control of significant EHS aspects affecting the Research Triangle Park site. This position will direct all EHS activities to maintain compliance with federal, state and local regulations and is the primary liaison with external regulatory agencies for the site.
Manage and continuously improve Health and Safety Programs in adherence to all Federal, State and Local requirements and AveXis policies, strategies, initiatives and goals.
The EHS programs managed by this position may include, but are not limited to: Environmental Permitting; Sustainability and Waste Management; Industrial Hygiene; Life Safety; other General Safety Programs including but not limited to, Control of Hazardous Energy, Confined Space Entry; Contractor Safety Management and Biosafety Management.
Manage and implement programs to foster a culture of safety and environmental stewardship within our business units. Duties may include performing safety workplace assessments; partnering with managers, supervisors, and employees to minimize occupational health and safety risks; teaching specific safe work habits and driving a behavior based safety program.
Assist with the development, improvement, and management of EHS Management Systems for the Research Triangle Park site. Develop and implement continuous improvement concepts to better the site's safety and environmental performance.
Implement, execute, and ensure compliance with AveXis' Environmental, Health & Safety policies and procedures.
Lead execution of the site's annual EHS Plan, including development of expense and capital budgets needed to support these efforts.
Build capability of site resources to support implementation of EHS programming.
Manage site-wide system, Program Element (PE) process, to identify and evaluate hazards (risks), and implement effective controls (corrective solutions).
Lead incident investigation process, including root cause analysis and identification of corrective action plans.
Interface with regulatory bodies (OSHA, EPA, State/Local Regulators).
Facilitate the completion of a site-wide annual HSE training plan.
Participate in formal EHS reviews of existing equipment modifications, new equipment purchases, and changes in site processes.
Ensure that required regulatory permits are acquired, that reports are submitted to regulatory agencies, and any site permit conditions (e.g. sampling, recordkeeping) are met.
EHS training development and execution.
Direct emergency response teams such as Emergency Evacuation and Spill Response Teams.
Lead and participate in inspections and audits.
Other tasks as required.
Degree in Occupational EHS discipline is required, Science or Engineering preferred.
Professional EHS certification or the desire to attain certification (CIH, CSP, CHMM, and / or PE) is strongly preferred.
8+ years of Environmental, Health & Safety (HSE, EHS) experience in a manufacturing environment required.
Functional EHS Knowledge in regulatory requirements, EHS technical aspects (safety, industrial hygiene, environmental), risk management, behavior-based safety, training, auditing / program review, regulatory agency enforcement, EHS vendor / consultant management, business knowledge required.
Proven track record in driving cultural change in EHS.
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.
Influence a philosophy of strategic safety training and ensure the Worker's Compensation Claim Management program is administered in an effective and compliant manner.
Provide business consultation to plant leadership team regarding the social system of the plant operations.
Cultivate employee commitment to a high-performance culture.
Actively participate in Plant 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.