The posting
Job Description
About Us
Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.
At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, and we strive to celebrate our employees in a positive environment.
Our culture empowers everyone to be successful and apply their full potential.
About the Role
Reporting to the Founder Novitium Pharma (currently titled Head of R&D and COO NJ Operations), the Director, Environmental Health & Safety will lead site-wide safety programs, training, and incident-prevention initiatives, ensure full compliance with OSHA and other applicable regulations, and partner closely with Operations, Quality, Engineering, HR to reduce injuries, improve safety performance, and embed “safety first” thinking into everyday decisions. This role will use data, risk assessments, and frontline engagement to deliver on outcomes. The role will oversee the integration of environmental stewardship into all safety initiatives and foster a culture in which environmental regulations are prioritized.
Responsibilities
- Set the strategic Environmental, Health & Safety vision for the East Windsor development and manufacturing facility, aligned with ANI’s mission and health and safety expectations.
- Develop, implement, and continuously improve Environmental, Health & Safety policies, procedures, and programs across labs, manufacturing suites, packaging, utilities, and warehouse operations.
- Ensure compliance with OSHA and applicable federal, state, and local requirements, integrating FDA/cGMP and ANI quality and compliance standards.
- Lead risk assessments and hazard evaluations; drive engineering and administrative controls that enable safe handling and manufacture of complex and potent products.
- Conduct and complete Job Hazard Analysis (JHA) reports to identify potential risks and implement preventive measures.
- Implement and oversee environmental management programs to ensure compliance with local, state, and federal environmental regulations, focusing on waste management, pollution prevention, and sustainable practices.
- Conduct environmental risk assessments to identify potential impacts of manufacturing processes on the environment, and develop strategies to mitigate these risks, fostering a culture of environmental responsibility throughout the site
- Oversee incident and near-miss investigations, root cause analysis, and CAPAs; track and communicate trends to prevent recurrence and support reliable supply to patients.
- Own the site Health & Safety training program, including onboarding, refresher, role-specific, and contractor safety training.
- Lead safety walks, inspections, and audits; partner with functional leaders to promptly address unsafe acts and conditions and reinforce cGMP-aligned safe work practices.
- Chair safety committees and huddles; engage employees in hazard identification, solution-finding, and recognition of safe behaviors to strengthen a patient-centric culture.
- Maintain and enhance Health & Safety management systems (SOPs, JHAs, permit-to-work, LOTO, confined space, PPE, incident reporting) in line with ANI standards.
- Oversee emergency preparedness and response, including drills, coordination with local agencies, and post-event reviews.
- Serve as primary Health & Safety liaison for East Windsor with corporate EHS, Quality, Operations, Regulatory, auditors, and external partners.
- Report Health & Safety performance and recommendations to site and corporate leadership; champion a proactive, “safety-first” culture across all shifts.
Skills
- Familiarity with environmental laws and regulations, including RCRA, Clean Air Act, Clean Water Act, and state-specific regulations, ensuring compliance and best practices in environmental management.
- Experience implementing sustainability initiatives and waste reduction programs, promoting environmentally responsible practices within the organization. Proven ability to build and sustain a strong safety culture in a fast-paced, cGMP-regulated environment.
- Deep knowledge of OSHA and best practices in occupational safety, industrial hygiene, ergonomics, and machine/production safety, and how they intersect FDA/cGMP expectations.
- Strong risk-assessment and problem-solving skills, including JHAs, root cause analysis, and risk-ranking tools applied to oral solid dose, liquids, suspensions, and potent/complex products.
- Excellent communication and facilitation skills; able to translate technical and regulatory requirements into practical guidance for operators, scientists, engineers, and leaders.
- Demonstrated ability to influence without authority and partner effectively with Operations, Quality, R&D, Engineering, HR, Facilities, and corporate EHS.
- Solid people-leadership capabilities, including coaching, feedback, and change management, with a track record of driving employee engagement in safety.
- Strong analytical skills; uses data and leading/lagging indicators to prioritize initiatives and measure Health & Safety performance.
- Highly organized and able to manage multiple projects, audits, and initiatives across development, commercial generics, and CDMO activities.
- Skilled with Microsoft Office and EHS management systems; capable of producing clear documentation, training materials, and inspection-ready reports.
Requirements
- Minimum of 8–10 years of progressive Environmental, Health & Safety experience in pharmaceutical, biotech, specialty chemical, or similarly regulated manufacturing environments; generics and/or CDMO experience strongly preferred.
- Prior site-level leadership of Environmental, Health & Safety programs (multi-suite, multi-shift operations strongly preferred), with direct people-leadership experience.
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Occupational Health & Safety, Environmental/Industrial Hygiene, Business or a related technical field; advanced degree a plus.
- Proven experience developing, implementing, and maintaining Environmental Management Systems (EMS) aligned with ISO 14001 or similar standards.
- Deep working knowledge of OSHA and relevant New Jersey regulations, plus strong understanding of FDA, cGMP, and data-integrity expectations for development and commercial manufacturing.
- Demonstrated success implementing and sustaining Environmental, Health & Safety management systems, procedures, and programs in a cGMP or highly regulated setting that manufactures prescription products.
- Proven record of effective incident investigations, root cause analysis, and durable corrective and preventive actions in manufacturing or R&D environments.
- Experience designing and delivering safety training to diverse audiences, including operators, technical staff, and leadership.
- Professional certifications such as CSP, CIH, CHMM, or equivalent, and/or OSHA 30/OSHA 500-level training strongly preferred.
- Ability to be onsite full-time at the East Windsor, NJ Novitium facility and support off-shift operations as needed, with occasional travel to other ANI locations or external meetings.
The base salary range for this position is $180,000 - $210,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results.
