US Director, Health Safety & Environment (HSE)

AdvanCell•Andover, MA

14h

About The Position

The Director of Health, Safety & Environment (HSE) develops, implements, and maintains HSE programs and systems for AdvanCell's Andover manufacturing site. The role oversees HSE across manufacturing, laboratories, utilities, infrastructure, warehouse and logistics operations, waste management, contractor activities, and administrative areas. While the site is under construction, the Director will establish the HSE organization, systems, processes, and culture needed to support safe construction, commissioning, qualification, startup, and transition to GMP manufacturing. The role partners with Engineering, Infrastructure, Manufacturing, MSAT, Quality, and other functional leaders to integrate HSE requirements into facility development and operational readiness. A particular focus is establishing and maintaining radiation safety programs for radiopharmaceutical manufacturing and radioactive materials. Following startup, the Director assumes full ownership of the site's HSE Management System and ongoing HSE performance, encompassing occupational health and safety, radiation safety, environmental compliance, hazardous materials, emergency preparedness, industrial hygiene, contractor safety, waste management, and regulatory compliance. As a member of the Andover Site Leadership Team, the Director contributes to strategic planning, organizational development, operational readiness, and cross-functional decision-making as the site grows into full GMP manufacturing and future commercial operations.

Requirements

Bachelor's degree in occupational health and safety, environmental science, engineering, science, radiation protection, health physics, or a related technical discipline; a bachelor's degree is required.
10+ years of progressive HSE experience, including significant experience leading HSE teams and programs in a manufacturing environment.
Demonstrated experience working in a GMP-regulated manufacturing environment; pharmaceutical, biotechnology, radiopharmaceutical, specialty chemical, or similarly regulated manufacturing experience is preferred.
Proven experience developing, implementing, and managing HSE programs and HSE Management Systems in manufacturing.
Strong knowledge of U.S. federal and state occupational health and safety requirements, including OSHA and applicable Massachusetts requirements.
Experience implementing and managing environmental compliance programs under federal and state regulatory requirements.
Experience interfacing with regulatory agencies on environmental, health, safety, and radiation protection requirements.
Demonstrated experience managing radiation safety programs and/or radioactive materials in a regulated manufacturing, pharmaceutical, medical, research, or industrial environment.
Strong knowledge of hazardous chemical management, industrial hygiene, occupational exposure assessment, emergency preparedness, and risk management.
Experience leading regulatory inspections, audits, licensing activities, and compliance programs.

Nice To Haves

Experience in radiopharmaceutical manufacturing, isotope production, radioactive materials processing, or another radioisotope-related manufacturing environment.
Experience serving as or working closely with a Radiation Safety Officer or equivalent radiation protection leader.
Experience with NRC or Agreement State radioactive materials licensing and regulatory requirements.
Experience building HSE programs for a new manufacturing facility and supporting startup, commissioning, qualification, and operational readiness.
Experience with environmental permitting, regulated waste management, hazardous waste, air permitting, wastewater, and environmental compliance in manufacturing.
Experience with process safety, hazardous chemical management, industrial hygiene, and emergency response in pharmaceutical or chemical manufacturing.

Responsibilities

Build an HSE organization with the capability, capacity, and culture to support safe, compliant, and efficient operations.
Define HSE priorities and a roadmap, and implement systems and processes using internal expertise and external best practices.
Establish the site's HSE Management System, including policies, procedures, risk management, training, metrics, governance, audits, and compliance systems.
Lead the site HSE function and embed safety, environmental, and radiation protection considerations throughout facility development, project delivery, commissioning, and startup.
Provide HSE guidance and oversight during construction and project execution, including design, startup planning, contractor safety, hazardous materials management, emergency preparedness, and operational readiness.
Partner with Engineering and Infrastructure to incorporate HSE requirements into facility design, construction, commissioning, qualification, and startup.
Develop and implement radiation safety programs, including radiation protection procedures, monitoring, dose management, contamination controls, training, records, and emergency response.
Lead development and submission of the Andover radioactive materials license application to the Massachusetts Department of Public Health, Division of Radiation Control, and establish the supporting program, procedures, qualifications, controls, monitoring, and documentation.
Serve as the primary site HSE interface with the Massachusetts Radiation Control Program during licensing, regulatory inquiries, inspections, and follow-up on findings.
Ensure the site is prepared to possess, use, transfer, and manage radioactive materials in accordance with its approved license and applicable Massachusetts requirements.
Develop environmental compliance programs for hazardous and radioactive waste, air emissions, wastewater, stormwater, spill prevention, and applicable permits and reporting.
Establish hazardous chemical and dangerous goods programs covering storage, handling, labeling, exposure controls, waste management, and emergency response.
Develop and implement emergency preparedness and response plans for radiation, chemical, fire, medical, environmental, and facility emergencies.
Establish HSE requirements and governance for construction contractors, vendors, visitors, and third-party service providers.
Develop HSE training and competency requirements for employees and contractors before startup and GMP operations.
Establish HSE inspection, audit, incident reporting, investigation, corrective action, and management review processes.
Develop HSE metrics, dashboards, leading and lagging indicators, and reporting mechanisms for site readiness and performance.
Build relationships with federal, state, and local regulatory agencies and support inspections, licensing, permits, and approvals.
Ensure HSE regulatory and inspection readiness before GMP manufacturing startup.
Partner with Quality to integrate HSE into GMP systems, investigations, CAPA, change control, training, and inspection readiness.
Partner with Manufacturing, Engineering, Infrastructure, Quality, Regulatory, Supply Chain, CMC, and R&D to incorporate HSE into operational readiness plans.
Establish a strong safety culture and embed HSE in facility design, construction, commissioning, and operations.