Assoc. Dir., Safety & Environment

Merck • Wilmington, DE

1d • $129,000 - $203,100

About The Position

Our Company's is a trusted global leader in human and veterinary medicine, dedicated to preserving and improving health, well-being and performance. Our Wilmington Biotech facility is a new state-of-the-art high potent biologics manufacturing facility for potent drug substance and drug product, including Antibody Drug Conjugates (ADCs), partnered closely with our Research & Development Division to commercialize, launch and supply products with speed, agility and innovation. We are seeking an experienced Safety & Environment (S&E) Associate Director with a strong safety focus to help build the EHS function at our new site. The successful candidate will provide industrial hygiene expertise and EHS general support through project construction, operational readiness, and future operation of the facility. As a key member of the site’s Global Safety & Environment (GSE) team, you will help shape the site EHS programs and culture, driving compliance, and embedding EHS excellence across all operations. The role combines strategic planning with hands-on execution and requires strong influencing skills to drive EHS performance within a complex, matrixed organization. Reporting to the site Safety & Environment Director at the new Wilmington Biotech Facility, the S&E Associate Director will provide technical and regulatory expertise and leadership to implement all environmental and safety programs required by federal, state, and local laws, as well as by Company policies. The S&E Associate Director will set direction and lead the planning, development, and periodic review of site safety and industrial hygiene programs. In this role, you will drive the industrial hygiene program at the new facility and will participate as a key stakeholder to establish a robust chemical management program across all operations at the facility.

Requirements

• Bachelor’s degree in environmental science, occupational health and safety, engineering, or related technical field
• 8+ years of professional EHS experience in chemical, biotechnology, or pharmaceutical manufacturing environments.
• Experience developing, implementing and managing EHS programs, including change management for operational or site initiatives.
• Ability to support multiple projects and effectively partner with regulatory agencies and internal business units.
• Deep experience ensuring compliance with internal and regulatory EHS requirements.
• Strong understanding of manufacturing processes and their relation to environmental and safety regulations.
• Practical competence in selecting respirators, suits, gloves, and face protection appropriate to task-specific exposure and compatibility with decontamination/solvent use.
• Understand applicable EHS regulatory requirements (OSHA, EPA, DOT, ISO, NFPA).
• Risk assessment, mitigation, and implementation of appropriate controls.
• Experience developing and implementing industrial hygiene program elements, including but not limited to:
• Strong knowledge of high potent drug manufacturing and plant operations for potent drug substance, drug product, laboratory, logistics and utilities.
• Developing and managing IH plans, including sampling strategies, selection and use of analytical methods, containment verification, and cleaning efficacy.
• Familiarity with isolators, containment enclosures, closed transfer systems, biological safety cabinets (BSCs), local exhaust ventilation (LEV), negative-pressure rooms, and barrier/airlock design specifically for high-potency compounds.
• Experience participating in and conducting task-based exposure assessments, and standardized risk ranking for manufacturing operations.
• Strong skills in preparing SOPs, exposure assessment reports, training records, risk assessments, incident reports, and supporting documentation for internal and external audits/inspections.
• Experience developing and implementing sustainable EHS operational procedures and training programs across a broad range of EHS subject areas.

Nice To Haves

• Master’s degree
• relevant professional certifications (e.g. CSP, CIH, CHMM, PE).
• 2–3+ years of experience in pharmaceutical manufacturing.
• Strong understanding of effective biological safety, emergency response and preparedness, chemical management and high-risk work (hazardous energy control, line break, hot work, electrical safety, elevated work, confined space entry, mobile crane, excavation/ trenching) programs.

Responsibilities

• Plan, develop and implement EHS programs to ensure continuous compliance with local, state and federal legislation, Company standards and industry best practices.
• Drive continuous improvement to strengthen EHS and Sustainability performance and close gaps identified through assessments and action plans.
• Investigate and mitigate risks across environmental, health, safety, and sustainability aspects.
• Ensure comprehensive change management of all EHS and site initiatives to ensure ongoing compliance in a dynamic and fast-paced environment.
• Develop site EHS training content, training matrix and assignments to ensure regulatory compliance, and development of employee skills to minimize risks. Conduct EHS training where appropriate.
• Coach operations leaders to enable them to successfully execute their leadership responsibilities for safety and environment. Partner with Wilmington Biotech departments and contacts to integrate safety and environmental management systems into every phase of their operations, as measured by performance metrics.
• Assure completion of required reports to site, divisional and/or corporate management and regulatory agencies.
• Identify and communicate budgetary & capital needs to support site EHS initiatives, projects and programs.
• Interface with local governmental safety and environmental agencies.
• Lead exposure assessments and monitoring programs for employee protection, including chemical, physical and biologics agents
• Design, implement and validate containment strategies for site operations, including manufacturing, laboratory, logistics, and site utilities/ infrastructure.
• Perform risk assessments, support cleaning validation assessments, and consult on workplace exposure assessments.
• Advise and assure development of high-potency spill response procedures, decontamination protocols, and emergency drills including advising validation sampling post-event.
• Support design reviews, commissioning, and start‑up activities for capital projects and process changes to ensure environmental and safety requirements are incorporated (including permitting implications) using Management of Change (MOC) processes.
• Advise and support environmental permitting, compliance, monitoring and reporting programs.
• Identify, coach, and develop talent through mentoring team members and supporting their technical and leadership growth.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Director