Site HSE Specialist
About The Position
This role is responsible for supporting the expansion of the Durham campus to include Aseptic Drug Product operations. This vital position will develop, implement, and track completion of HSE deliverables and needs (e.g., design input, construction safety, HSE operational readiness prior to the start of operations). The role will support overall project success, as well as ensure robust implementation of HSE systems, programs, and controls prior to start of operations. This role is a Program Lead for designated occupational safety programs across the Durham campus. This role will support implementation of robust HSE programs to ensure the protection of associates and the environment, as well as adherence to all external regulations and internal HSE standards/policies. In addition, this role will contribute to a strong, proactive, and enabling HSE culture for the campus’s overall GTx/LMO/ADP operations.
Requirements
- 5+ years of HSE program development/management experience in a manufacturing/laboratory environment (preferably within the biopharmaceutical industry).
- Strong technical knowlege across HSE disciplines.
- BS degree or higher in Occupational Health & Safety, Chemical Engineering, or related field.
- Professional HSE certifications (e.g., CSP, CIH) or desire to attain them is strongly preferred.
- Prior experience supporting the design and startup of new ADP/LMO facilities and manufacturing operations (e.g., PHAs, P&ID/design documentation review, HSE operational readiness) highly desired.
- Strong influencer with the ability to work effectively and build relationships across a matrixed organization.
- Excellent communication and technical writing skills.
- Outstanding interpersonal skills for collaboration, creativity in problem solving, and ability to plan/perform multiple tasks with high quality as part of a high-paced work environment.
- Knowledge of cGMP manufacturing regulations and requirements in conjunction with the delivery of effective EHS programs.
Responsibilities
- Lead the implementation of robust HSE programs and controls to enable safe and compliant start-up of ADP production operations.
- Integrate ADP-specific HSE requirements into site-wide systems, processes, and training frameworks.
- Partner with external providers and internal teams to deliver world-class safety performance across construction and operations.
- Drive Occupational Safety excellence by developing and continuously improving critical programs (e.g., Process Safety, Electrical Safety, Fire Protection, Emergency Response).
- Collaborate cross-functionally to embed HSE practices that support reliable commercial production and research operations.
- Provide expert HSE guidance for new equipment, processes, and technology transfers, ensuring safe and efficient implementation.
- Lead HSE impact assessments and manage change to ensure compliance and risk mitigation across site operations.
- Act as a trusted technical expert, leading complex investigations and ensuring effective root cause analysis and resolution.
- Leverage HSE data, metrics, and insights to drive continuous improvement and deliver strong business outcomes.
- Champion a high-performance safety culture through training, governance, audits, regulatory engagement, and strong stakeholder collaboration.
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- a variety of other benefits
- a generous time off package including vacation, personal days, holidays and other leaves
- performance-based cash incentive
- eligibility to be considered for annual equity awards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
