US Director, Health Safety & Environment (HSE)
AdvanCell · Andover, MA · 1 mo ago
On-siteManagementFull-time
We need to output HTML fragment with sections: About the role (maybe from first paragraph?), Responsibilities (Key Responsibilities And Duties), Requirements (Essential Skills, Qualifications...), maybe Desired Skills separate? Could combine into Requirements and Desired Skills? The instruction: use headings for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include sections only when posting has real specific content. We have content for About the role (first paragraph describing role). Responsibilities (Key Responsibilities And Duties). Requirements (Essential Skills, Qualifications...). Desired Skills maybe could be under Skills or Qualifications? Could have separate Skills section? The posting includes "Essential Skills, Qualifications, Industry And Educational Requirements" and "Desired Skills, Qualifications, Industry And Educational Requirements". We could combine into Requirements and maybe a Skills subsection. But we need to follow headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have no Benefits, Pay, Schedule specifics (only a vague statement about salary range but it's generic "The range provided above is based on what we believe to be a reasonable estimate...". That's not specific numbers, it's vague. According to rule: never create Pay/Schedule/Benefits sections unless posting actually states them. It does mention salary range but not actual numbers; it's a generic statement. Likely we should not include Pay section. Benefits not mentioned. Schedule not mentioned. So we will include About the role, Responsibilities, Requirements, Qualifications, Skills maybe. But we have both essential and desired; we could put essential under Requirements and desired under Skills. Or we could combine both under Requirements and have Skills separate? Let's decide: About the role: first paragraph(s) up to "Success in this role requires strong leadership..." maybe that's part of About. Then Responsibilities: the bullet list under Key Responsibilities And Duties. Then Requirements: Essential Skills, Qualifications, Industry And Educational Requirements (the list). Then Skills: Desired Skills, Qualifications, Industry And Educational Requirements (the list). Ensure we don't repeat job title. Use for each section heading. Use
for each section heading. Use - for lists. Use
for prose.
We need to preserve all substantive information; do not invent or summarize away detail. So we need to include all bullet points from responsibilities and requirements.
Let's extract responsibilities list: It's a long paragraph with many items separated by semicolons? Actually the text after "Key Responsibilities And Duties" then a colon then list items each starting with a verb. They are separated by line breaks? In the source they appear as separate sentences but we can treat each as a list item. We'll need to break them into
- elements.
Let's copy the responsibilities text:
"Pre-Startup and Startup Phase: Build an HSE organization with the capability, capacity, and culture to support safe, compliant, and efficient operationsDefine HSE priorities and roadmap; implement systems and processes using internal expertise and external best practicesEstablish the site HSE Management System, including policies, procedures, risk management processes, training, metrics, governance, audit processes, and compliance systemsEstablish and lead the site HSE function, embedding safety, environmental, and radiation protection focus throughout facility development, project delivery, commissioning, and startupServe 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 readinessPartner with Engineering and Infrastructure to ensure HSE requirements are incorporated into facility design, construction, commissioning, qualification, and startup activitiesProvide HSE oversight and technical guidance during capital project executionDevelop and implement radiation safety programs appropriate for the site's radioactive materials and radiopharmaceutical manufacturing activitiesEstablish radiation protection procedures, monitoring programs, dose management, contamination controls, training, records, and emergency response capabilitiesLead 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 licenseServe 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 requirementsDevelop and implement environmental compliance programs, including hazardous and radioactive waste management, air emissions, wastewater, stormwater, spill prevention, and applicable permitting and reporting requirementsEstablish hazardous chemical and dangerous goods management programs, including storage, handling, labelling, exposure controls, waste management, and emergency responseDevelop and implement site emergency preparedness and response plans, including radiation, chemical, fire, medical, environmental, and facility emergency scenariosEstablish HSE requirements and governance for construction contractors, vendors, visitors, and third-party service providersDevelop HSE training and competency requirements for employees and contractors prior to startup and GMP operationsEstablish HSE inspection, audit, incident reporting, investigation, corrective action, and management review processesDevelop HSE metrics, dashboards, leading and lagging indicators, and reporting mechanisms to provide visibility into site readiness and performanceBuild relationships with applicable federal, state, and local regulatory agencies and support regulatory inspections, licensing activities, permits, and approvalsEnsure HSE regulatory and inspection readiness prior to GMP manufacturing startupPartner with Quality to integrate HSE requirements into GMP systems, investigations, CAPA, change control, training, and inspection readinessPartner with Manufacturing, Engineering, Infrastructure, Quality, Regulatory, Supply Chain, CMC, and R&D to ensure HSE requirements are incorporated into operational readiness plansEstablish a strong safety culture from the outset, ensuring HSE is embedded into how the site designs, builds, commissions, and operates the facility"
We need to split into sensible list items. The text seems to have missing punctuation; we can split at each capitalized verb after a period? Actually there are no periods except at end? The text seems to be a run-on. We'll need to infer items: Each item starts with a verb (Build, Define, Establish, Establish, Serve, Partner, Provide, Develop and implement, Establish, Lead, Serve, Develop and implement, Establish, Develop and implement, Establish, Develop, Establish, Develop, Build relationships, Ensure, Partner, Partner, Establish). That's many.
We'll create
- for each distinct responsibility. We'll try to separate by the pattern: after a lowercase letter then a capital letter? Eg "...operationsDefine" -> split before "Define". Similarly "...practicesEstablish" -> split before "Establish". We'll manually split.
Let's rewrite responsibilities as list:
- 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
Now Requirements (Essential Skills, Qualifications, Industry And Educational Requirements). The text:
"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"
We'll make list items.
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"
We'll make list under Skills.
Now About the role: we need to capture the introductory paragraphs before "Key Responsibilities And Duties". Let's extract:
"The Director of Health, Safety & Environment (HSE) is responsible for developing, implementing, and maintaining the H
for prose. We need to preserve all substantive information; do not invent or summarize away detail. So we need to include all bullet points from responsibilities and requirements. Let's extract responsibilities list: It's a long paragraph with many items separated by semicolons? Actually the text after "Key Responsibilities And Duties" then a colon then list items each starting with a verb. They are separated by line breaks? In the source they appear as separate sentences but we can treat each as a list item. We'll need to break them into