This is a critical leadership role responsible for establishing the EHS framework from scratch and building a robust, scalable, and compliant EHS program aligned with biopharmaceutical manufacturing operations, GMP standards, and global regulatory expectations.

Key Responsibilities:

1. Build and implement the company’s EHS strategy, policies, procedures, standards, and governance framework from the ground up.
2. Lead all EHS programs across biologics development and manufacturing operations, ensuring compliance with applicable local, regional, and international regulations.
3. Establish and maintain EHS management systems, metrics, audits, inspections, incident investigations, corrective actions, and management reviews.
4. Develop and drive a proactive safety culture, promoting employee engagement, accountability, and continuous improvement.
5. Ensure EHS practices are aligned with GMP operations and support cleanroom, laboratory, pilot plant, and manufacturing environments.
6. Oversee risk assessments, hazard identification, emergency preparedness, industrial hygiene, chemical safety, biosafety, and occupational health programs.
7. Lead environmental compliance activities, including waste management, emissions control, spill prevention, and sustainability initiatives as applicable.
8. Partner with Quality, Manufacturing, Engineering, Facilities, and Operations to support safe startup, process changes, equipment qualification, and operational readiness.
9. Develop and deliver EHS training programs to ensure employees and contractors understand requirements, responsibilities, and safe work practices.
10. Investigate incidents, near misses, and unsafe conditions; implement effective root cause analysis and preventive actions.
11. Support regulatory inspections, client audits, and internal assessments related to EHS and GMP compliance.
12. Manage external EHS consultants, vendors, and service providers as needed.
13. Report regularly to senior management on EHS performance, trends, risks, and improvement plans.
14. Serve as a trusted advisor to leadership on EHS strategy, compliance, and organizational risk mitigation.

Summary:

This position is ideal for a seasoned EHS leader with deep experience in biopharmaceutical or biologics manufacturing environments and a strong understanding of GMP requirements. The role requires both strategic leadership and hands-on execution to create an EHS function that supports a high-growth, science-driven organization.

Requirements:

1. Bachelor’s degree in Environmental Health and Safety, Industrial Hygiene, Occupational Health, Engineering, Life Sciences, or a related discipline; advanced degree preferred.
2. Minimum of 10+ years of EHS experience, with significant leadership experience in biopharmaceutical, biologics, pharmaceutical, or life sciences manufacturing environments.
3. Proven experience establishing an EHS framework, systems, and processes from scratch or leading major EHS transformation/build-out initiatives.
4. Biopharma experience is mandatory.
5. Strong familiarity with GMP requirements and the ability to integrate EHS practices into GMP-regulated operations.
6. Demonstrated knowledge of EHS regulations, risk management, incident investigation, industrial hygiene, emergency response, and environmental compliance.
7. Experience supporting cleanroom, laboratory, biologics manufacturing, and/or aseptic operations is highly desirable.
8. Strong leadership, communication, influencing, and stakeholder management skills with the ability to work across all organizational levels.
9. Ability to develop policies, SOPs, training programs, audit systems, and performance metrics.
10. Strong analytical and problem-solving skills with a practical, hands-on approach.
11. Experience working in global, matrixed, or regulated organizations preferred.
12. Ability to manage multiple priorities in a fast-paced, evolving environment.

Preferred Attributes:

1. Strategic thinker with the ability to build structure while driving operational execution.
2. Strong ownership and accountability to compliance, quality, and employee safety.
3. Collaborative leader who can influence change and build trust across functions.