Company: AveXis Inc.
Posted on: December 8, 2018
OverviewReady 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 an Environmental Specialist to 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: Environmental Permitting and reporting; Community Right to Know; Sustainability; and Waste Management. This position assists in assessing and managing key environmental risks which impact the site's 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.ResponsibilitiesImplement, execute, and ensure compliance with AveXis' overall Environmental, Health and Safety policies and procedures.Oversee Chemical Inventory Management for SDS Management and SARA Compliance.Superfund Authorization Reauthorization Act (SARA) 311-312 annual reporting.Manage compliance with NPDES, and Wastewater Disposal permit requirements. Manage Solid Waste Management Program (Hazardous/Non-Hazardous); Regulated Medical Waste).Responsible for waste recycling program (used lamps; batteries; glassware; etc.).Supervision of site's Storm-water Pollution Prevention Plan and Discharge Permit.Oversee Site's Spill Prevention Control and Countermeasure Plan (diesel fuel - generators).Participate in the incident investigation process, including root cause analysis and identification of corrective action plans related to environmental compliance/releases.Interface with regulatory bodies as applicable (EPA, State/Local Regulators).Facilitate the completion of a site-wide annual environmental training plan.Participate in formal reviews of existing equipment modifications, new equipment purchases, and changes in site processes to assess potential environmental impacts.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 the Spill Response Team.Lead and participate in inspections and audits. QualificationsBachelor's degree or higher in Occupational Health & Safety, Industrial Hygiene, Chemical Engineering.3+ years of Environmental,) experience in a manufacturing environment required.Functional knowledge in regulatory requirements, technical aspects, training, auditing / program review, regulatory agency enforcement, EHS waste vendor / consultant management. 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 Plant Environmental Audits.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 Plant Environmental 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.
Keywords: AveXis Inc., Durham , Environmental Specialist, Other , Durham, North Carolina
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