Job Summary
- Manager, Environment, Health & Safety (EH&S) serves as the site leader and primary subject matter expert for all EH&S programs at the Canton, Massachusetts GMP vaccine drug substance manufacturing site.
- Full ownership of establishing, implementing, and sustaining EH&S systems to support safe site start-up, regulatory readiness, and routine commercial operations.
- Accountable for compliance with OSHA, EPA, MassDEP, CDC/NIH, and applicable regulations, permits, and registrations.
- Partners cross-functionally to enable compliant, efficient, and safe manufacturing operations and to drive a proactive, risk-based safety culture aligned with cGMP.
Essential Functions
- Lead EH&S programs during site start-up, ramp-up, and steady-state GMP operations.
- Develop, implement, and continuously improve EH&S policies, procedures, and programs.
- Ensure compliance and readiness for regulatory inspections; own site EH&S permits/licenses and regulatory reporting.
- Liaise with regulators/auditors; lead inspections, responses, and closure of commitments.
- Provide strategic and hands-on support for facility readiness, commissioning, qualification, and operational risk assessments.
- Lead EH&S risk assessments (e.g., JSA, process hazard analysis, biosafety assessments).
- Own incident management (investigations, root cause analysis, CAPA).
- Establish and monitor EH&S performance metrics.
- Develop environmental compliance programs (hazardous waste, wastewater, air emissions, stormwater, chemical inventory/SDS).
- Oversee occupational health/industrial hygiene (medical surveillance, respiratory protection, ergonomics, exposure monitoring, hearing conservation).
- Lead contractor safety and permit-to-work programs.
- Review/approve SOPs, change controls, deviations, and capital projects for EH&S risk control aligned with GMP.
- Drive EH&S engagement, training, and leadership visibility.
- Collaborate with corporate EH&S to align with enterprise standards.
- Serve as responsible/alternate official for biosafety, biosecurity, and select agent programs (as applicable).
Minimum Education, Experience, Skills
- Bachelorβs degree in relevant discipline required (advanced degree preferred).
- 8+ years progressive EH&S experience with site-level ownership in regulated manufacturing.
- Strong cGMP pharmaceutical/vaccine/biologics/biotechnology manufacturing experience, including start-up or commissioning.
- Deep knowledge of OSHA, EPA, and state/local environmental regulations (MassDEP preferred).
- Proven track record leading EH&S inspections/audits and managing responses/CAPA.
- Experience managing biologics/vaccine drug substance EH&S risks (biosafety, chemical hazards, high-containment considerations).
- Knowledge of EH&S management systems (e.g., ISO 14001, ISO 45001) integrated into GMP.
- Ability to operate independently as site EH&S lead and drive results.
- Excellent communication and stakeholder management with regulators and cross-functional teams.
- CSP/CIH/CHMM or equivalent strongly preferred (or ability to obtain within a defined timeframe).
Application Instructions
- If interviewing, discuss interest with your current manager prior to scheduling.