Manager, EHS

JOB SUMMARY

The 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 (DS) manufacturing site. Operating as an individual contributor, this role has full ownership for establishing, implementing, and sustaining EH&S systems to support safe site start-up, regulatory readiness, and routine commercial operations. The Manager is accountable for ensuring compliance with OSHA, EPA, MassDEP, CDC/NIH, and all applicable federal, state, and local regulations, permits, and registrations. This role partners cross-functionally with Site Leadership, Manufacturing, Quality, Engineering, and external agencies to enable compliant, efficient, and safe manufacturing operations while driving a proactive, risk-based safety culture aligned with cGMP expectations.

ESSENTIAL FUNCTIONS

• Serve as the site EH&S leader and single point of accountability for all environmental, health, and safety programs during site start-up, ramp-up, and steady-state GMP operations.
• Lead the development, implementation, and continuous improvement of EH&S programs, policies, and procedures to support a GMP-compliant vaccine drug substance manufacturing environment.
• Ensure full compliance and ongoing readiness for OSHA, EPA, MassDEP, local fire department, and other regulatory inspections; own all site EH&S permits, licenses, and regulatory reporting obligations.
• Act as the primary liaison with regulatory authorities, auditors, and external partners; lead site inspections, responses, and closure of commitments.
• Provide strategic and hands-on EH&S support to site start-up activities including facility readiness, commissioning, qualification, and operational risk assessments.
• Lead and execute comprehensive EH&S risk assessments (e.g., JSA, process hazard analysis, biosafety assessments) to identify and mitigate risks associated with biologics manufacturing, laboratories, utilities, and support functions.
• Own incident management processes including investigations, root cause analysis, and implementation of effective corrective and preventive actions; ensure timely reporting and closure.
• Establish and monitor EH&S performance metrics; analyze trends and provide data-driven insights and recommendations to site leadership.
• Develop and maintain environmental compliance programs including hazardous waste, wastewater discharge, air emissions, stormwater, and chemical inventory/SDS systems.
• Oversee occupational health and industrial hygiene programs including medical surveillance, respiratory protection, ergonomics, exposure monitoring, and hearing conservation.
• Lead contractor safety and permit-to-work programs (e.g., hot work, confined space, line break), ensuring safe execution of construction, maintenance, and engineering activities.
• Review and approve SOPs, change controls, deviations, and capital projects to ensure EH&S risks are identified and controlled in alignment with GMP requirements.
• Support and influence site culture by driving EH&S engagement, training programs, and leadership visibility across all levels of the organization.
• Collaborate with corporate EH&S and functional partners to align site practices with enterprise standards, regulatory expectations, and industry best practices.
• Serve as responsible or alternate official for biosafety, biosecurity, and select agent programs, as applicable to vaccine drug substance operations.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in Environmental Health & Safety, Industrial Hygiene, Environmental Science, Engineering, Biology, Chemistry, or related technical discipline required; advanced degree preferred.
• Minimum of eight (8) years of progressive EH&S experience, including demonstrated ownership of site-level EH&S programs in a regulated manufacturing environment.
• Strong experience in cGMP pharmaceutical, vaccine, biologics, or biotechnology manufacturing operations, including start-up or facility commissioning experience.
• Deep knowledge of OSHA, EPA, and state/local environmental regulations (MassDEP experience preferred), including permitting, inspections, and regulatory reporting.
• Proven track record of leading EH&S related inspections and audits and successfully managing responses and corrective actions.
• Experience managing EH&S risks in biologics or vaccine drug substance environments, including biosafety, chemical hazards, and high-containment considerations.
• Strong working knowledge of EH&S management systems and frameworks (e.g., ISO 14001, ISO 45001) and their integration into GMP operations.
• Demonstrated ability to operate independently as a site EH&S lead, prioritize competing demands, and drive results in a fast-paced environment.
• Excellent communication, influencing, and stakeholder management skills, with the ability to effectively engage senior leadership, regulators, and cross-functional teams.
• Professional certification such as CSP, CIH, CHMM, or equivalent strongly preferred or ability to obtain within a defined timeframe.