US Director, Health Safety & Environment (HSE)

Key Responsibilities and Duties

Pre-Startup and Startup Phase:

Build an HSE organization with the capability, capacity, and culture to support safe, compliant, and efficient operations.

Define HSE priorities and roadmap; implement systems and processes using internal expertise and external best practices.

Establish the site HSE Management System, including policies, procedures, risk management processes, training, metrics, governance, audit processes, and compliance systems.

Establish and lead the site HSE function, embedding safety, environmental, and radiation protection focus throughout facility development, project delivery, commissioning, and startup.

Serve as a key HSE stakeholder during facility construction and project execution, providing HSE guidance and oversight for design, startup planning, contractor safety, hazardous materials management, emergency preparedness, and operational readiness.

Partner with Engineering and Infrastructure to ensure HSE requirements are incorporated into facility design, construction, commissioning, qualification, and startup activities.

Provide HSE oversight and technical guidance during capital project execution.

Develop and implement radiation safety programs appropriate for the site's radioactive materials and radiopharmaceutical manufacturing activities.

Establish radiation protection procedures, monitoring programs, dose management, contamination controls, training, records, and emergency response capabilities.

Lead the development and submission of the Andover site's radioactive materials license application to the Massachusetts Department of Public Health, Division of Radiation Control, including establishing the required radiation safety program, operating procedures, personnel qualifications, facility controls, monitoring programs, and supporting documentation necessary to obtain and maintain the license.

Serve as the primary site HSE interface with the Massachusetts Radiation Control Program throughout the licensing process, including responding to regulatory questions, coordinating inspections, addressing findings, and ensuring the site is fully prepared to possess, use, transfer, and manage radioactive materials in accordance with the approved license and applicable Massachusetts requirements.

Develop and implement environmental compliance programs, including hazardous and radioactive waste management, air emissions, wastewater, stormwater, spill prevention, and applicable permitting and reporting requirements.

Establish hazardous chemical and dangerous goods management programs, including storage, handling, labelling, exposure controls, waste management, and emergency response.

Develop and implement site emergency preparedness and response plans, including radiation, chemical, fire, medical, environmental, and facility emergency scenarios.

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 prior to 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 to provide visibility into site readiness and performance.

Build relationships with applicable federal, state, and local regulatory agencies and support regulatory inspections, licensing activities, permits, and approvals.

Ensure HSE regulatory and inspection readiness prior to GMP manufacturing startup.

Partner with Quality to integrate HSE requirements 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 ensure HSE requirements are incorporated into operational readiness plans.

Establish a strong safety culture from the outset, ensuring HSE is embedded into how the site designs, builds, commissions, and operates the facility.

Essential Skills, Qualifications, Industry and Educational Requirements

Bachelor's degree required, preferably in occupational health and safety, environmental science, engineering, science, radiation protection, health physics or related technical discipline.
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 is required, preferably within pharmaceutical, biotechnology, radiopharmaceutical, specialty chemical, or similarly regulated manufacturing.
Proven experience developing, implementing, and managing HSE programs and HSE Management Systems in a manufacturing setting.
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 in accordance with 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.

Desired Skills, Qualifications, Industry and Educational Requirements

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 leadership function.
Experience with NRC or Agreement State radioactive materials licensing and regulatory requirements.
Experience building HSE programs for a new manufacturing facility and supporting facility startup, commissioning, qualification, and operational readiness.
Experience with environmental permitting, regulated waste management, hazardous waste, air permitting, wastewater, and environmental compliance programs in a manufacturing setting.
Experience with process safety, hazardous chemical management, industrial hygiene, and emergency response in a pharmaceutical or chemical manufacturing environment.