Environment, Health and Safety Manager

Job Purpose:

The Manager, Health, Safety and Environment, is responsible for supporting the expansion of Durham campus operations to include Large Molecule drug substance production at our new facility in RTP, NC. 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. The role will be on the LMO SLT and act as primary point of contact to that platform providing expert support across HSE topics.

This role will be the Functional Lead for Occupational Safety programs across the Durham campus’s overall Gene Therapy/LMO/ADP operations. This role will lead implementation of robust HSE programs to ensure the protection of associated and the environment while simultaneously contributing to a strong, proactive, and enabling HSE culture.

Key Responsibilities:

Assess, identify, and implement strong HSE programs and controls prior to start of LMO production operations (e.g., PHA actions, new/updated site plans/procedures/permits, qualification of safety maintenance & control equipment/devices, task-based risk assessments/JSAs, lockout/tagout procedures).

Ensure robust integration of LMO-specific HSE aspects into the overall Durham campus framework for HSE written plans and processes, training curriculums, and associate/department support processes.

Provide oversight and engagement with external service providers in support to world class construction safety performance.

Acts as HSE primary point of contact for assigned platform(s) providing expert advice on HSE risks, controls, and regulatory requirements. Supports transparent and accurate HSE reporting, as well as escalation and management of significant HSE risks and compliance requirements.

Functional Lead for Occupational Safety programs across the Durham campus (e.g, Process Safety, Lockout/Tagout, Electrical Safety, Machine Guarding, Line Break, Fire Protection, Emergency Preparedness & Response, Fall Protection, Powered Industrial Vehicles).

Works closely with various Departments to incorporate HSE initiatives/goals into their daily operations, which connect to the overall HSE strategy and focus areas at the site.

Identifies, establishes, and tracks robust HSE metrics in support to production operations and site HSE strategy/goals. Support both site and above-site HSE KPI reporting and trending for Durham’s performance.

Oversee and ensure implementation of initiatives that build HSE capabilities and knowledge within production units and across the campus, including comprehensive HSE training programs, safety committees/teams, and employee/department engagement processes.

Ensures appropriate HSE technical evaluation and controls for new operations/equipment prior to start-up, as well as provides leadership for HSE assessments of new product/process tech transfers.

Leads HSE impact assessments and manages the closure of HSE changes/updates tied to designated production units or site initiatives/changes.

Serve as a senior-level HSE technical and scientific lead for production, laboratory or facility issues, as well as complex HSE investigations to ensure appropriate root cause analyses, CAPA definition, and overall troubleshooting and resolution.

Ensures thorough hazard characterizations for new chemical/biological materials (e.g. hazard class, biological safety level), as well as works closely with Departments to ensure a robust inventory management program.

Ensures thorough HSE risk assessments (e.g., HAZOP, qualitative task-based JSAs, quantitative air sampling) tied to new manufacturing, laboratories, or facility operations/equipment.

Performs and documents robust site inspections/walkthroughs and compliance checks.

Maintains an awareness of new/updated HSE regulations or Client standards and supports implementation of programs/work practices to meet or exceed requirements.

Manages cross-functional Emergency Response Programs/Teams as well as Site Safety Committees.

Acts as the Subject Matter Expert in regulatory inspections and/or inquiries involving environmental, health, and safety programs.

Be an influential conduit to all staff/departments with the focus of building/maintaining a high performing EHS culture where all staff are enabled to support success.

Other related duties as assigned.

Qualifications

Bachelor’s or Master’s degree in Occupational Health & Safety, Environmental Science, Engineering, Biology, or related field.

Professional HSE certifications (e.g., CSP, CIH or equivalent) highly desired.

Experience / Skills

8+ years of HSE program development/management experience in a manufacturing/laboratory environment, preferably within the biopharmaceutical industry.

Prior experience supporting the design and startup of new LMO/ADP facilities and manufacturing operations (e.g., PHAs, P&ID/design documentation review, HSE operational readiness) highly desired.

Outstanding interpersonal skills for coaching and collaboration. Ability to adapt communication styles based on audience and effectively advise on complex matters.

Creative problem solver, strong multi-tasker, and excellent oral and written communication skills.