The Environmental Health and Safety (EHS) Manager will be responsible for establishing and leading all EHS programs, policies, and procedures for the Branchburg manufacturing facility. As a foundational role in a greenfield site startup, the EHS Manager will develop and implement systems that ensure full compliance with OSHA, EPA, DEA, local, and global regulatory requirements. This leader will foster a proactive safety culture, drive risk reduction strategies, and ensure a safe, healthy, and environmentally responsible workplace across sterile manufacturing, utilities, laboratory operations, and administrative functions. The role will also oversee EHS compliance and physical security requirements for the handling, storage, and disposal of controlled substances and high-potency active pharmaceutical ingredients (HPAPIs).

Key Responsibilities

  1. Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.
  2. Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.
  3. Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.
  4. Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.
  5. Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.
  6. Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.
  7. Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.
  8. Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.
  9. Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.
  10. Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.
  11. Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.
  12. Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.

Key Stakeholders

Internal:

  • Site Leadership Team (Operations, Quality, Engineering, Supply Chain, HR, Security)
  • Manufacturing, Maintenance, and Laboratory Staff
  • Corporate EHS, Regulatory Affairs, and Legal/Compliance functions

External:

  • OSHA, EPA, NJDEP, DEA, and local regulatory authorities
  • Environmental and industrial hygiene consultants
  • Controlled substance waste disposal vendors
  • Fire departments, emergency responders, and law enforcement

Qualifications / Experience

  • Bachelor’s degree in Environmental Science, Occupational Health & Safety, Chemical Engineering, or related field (Master’s preferred)
  • Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment
  • Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred
  • In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines
  • Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds
  • Experience leading EHS activities during greenfield/startup site development and qualification is a plus

Skills / Competencies

  • Strong understanding of DEA regulations and physical security principles for controlled substances
  • Demonstrated ability to build and scale EHS systems and teams in a dynamic environment
  • Strong leadership presence and communication skills across all organizational levels
  • Expertise in EHS training, auditing, incident investigation, and regulatory reporting
  • Strategic thinker with attention to detail and a hands-on, proactive mindset
  • Commitment to protecting personnel, the environment, and the integrity of regulated substances