We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.
A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
Position Summary
The Manager, Process Safety is responsible for leading and continuously improving the site's Process Safety Management (PSM), Electrical Safety, and Energy Control programs. This position serves as the site Subject Matter Expert (SME) for process safety and operational risk management, ensuring compliance with applicable federal, state, and local regulations, industry standards, and company policies while supporting safe, reliable, and compliant manufacturing operations. Additionally, this position will be the lead HSE contributor for maintenance of LOTTE’s International Organization for Standardization (ISO) 45001 certification.
The position partners closely with Operations, Engineering, Facilities, Maintenance, Quality, Validation, and Corporate HSE to identify, assess, and mitigate risks associated with manufacturing processes, utilities, equipment, and facility operations. This position drives a proactive safety culture through technical expertise, risk-based decision-making, regulatory compliance, and continuous improvement initiatives.
This position must comply with all Security requirements, Health, Safety, and Environment (HSE) regulations, and current Good Manufacturing Practices (cGMPs) applicable to the job function.
Duties & Responsibilities
- Serve as the site Subject Matter Expert (SME) for Process Safety Management (PSM), Electrical Safety, and Energy Control (LOTO) programs.
- Lead the implementation, maintenance, and continuous improvement of site Process Safety Management programs to ensure compliance with OSHA PSM, EPA Risk Management Program (RMP), NFPA requirements, and company standards.
- Facilitate Process Hazard Analyses (PHA), HAZOP studies, risk assessments, and other structured hazard evaluation processes to identify, assess, and mitigate operational risks.
- Manage the site's Management of Change (MOC) program, ensuring health, safety, environmental, quality, and operational risks are appropriately evaluated and controlled prior to implementation.
- Partner with Operations, Engineering, Facilities, Maintenance, and Quality teams to integrate process safety principles into manufacturing operations and business processes.
- Support the design, installation, startup, qualification, and modification of manufacturing equipment, utility systems, facilities, and processes to ensure safety and regulatory requirements are met.
- Administer and continuously improve Electrical Safety and Energy Control programs, including Arc Flash assessments, Lockout/Tagout compliance, training programs, and risk mitigation activities.
- Lead process safety reviews associated with new technologies, capital projects, process modifications, and equipment installations.\
- Coordinate internal and external ISO45001 audits with third-party consultants and internal resources. Contribute to other ISO certifications as assigned.
- Execute industrial hygiene exposure monitoring in coordination with the site’s Industrial Hygienist.
- Act as the HSE representative for client projects as assigned.
- Conduct compliance audits, inspections, program assessments, and field observations to evaluate effectiveness of safety controls and identify opportunities for improvement.
- Lead or facilitate incident investigations, root cause analyses, and development of corrective and preventive actions (CAPAs) related to safety, process safety, and operational events.
- Monitor, analyze, and report process safety and HSE metrics, key performance indicators (KPIs), and leading indicators to drive continuous improvement.
- Maintain regulatory records, compliance documentation, and required reports for internal and external stakeholders.
- Support contractor safety and qualification programs to ensure adherence to company safety requirements and industry best practices.
- Serve as a site representative during regulatory inspections, customer audits, and corporate assessments related to process safety and HSE compliance.
- Deliver technical training, coaching, and guidance on process safety, hazard recognition, risk mitigation, and regulatory requirements.
- Participate in emergency response planning and provide technical support during emergency events and operational incidents.
- Stay current with emerging process safety technologies, regulatory developments, and industry best practices to enhance site performance.
- Support the Senior Manager, HSE with departmental objectives, strategic initiatives, budgeting activities, and continuous improvement efforts.
- Participate on cross-functional teams, committees, and corporate initiatives as required.
- Perform other duties as assigned.
Education & Experience
- Bachelor's degree in Environmental Health & Safety, Engineering, Industrial Hygiene, Chemistry, Biology, Occupational Health, or a related discipline required.
- 7+ years of experience in Process Safety, Health, Safety & Environment (HSE), Operational Risk Management, or HSE program leadership within pharmaceutical, biologics, biotechnology, chemical, or other highly regulated manufacturing environments.
- Demonstrated success leading risk assessments, process safety initiatives, incident investigations, and regulatory compliance programs.
- Experience supporting enterprise-wide process safety and operational risk initiatives across complex manufacturing operations.
- Professional certification such as: Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), Certified Process Safety Professional (CCPSC), or an equivalent credential preferred.
- Knowledge of Arc Flash hazards, electrical safety, and NFPA 70E compliance programs preferred.
Knowledge, Skills, Abilities
- Strong knowledge of OSHA Process Safety Management (PSM), EPA Risk Management Program (RMP), NFPA standards, Electrical Safety, and Energy Control (LOTO) requirements.
- Experience conducting Process Hazard Analyses (PHA), HAZOPs, risk assessments, incident investigations, and Management of Change (MOC) reviews.
- Experience with the ISO45001 standard and maintaining a certified occupational health and safety management system.
- Familiarity with standard industrial hygiene monitoring techniques including noise dosimetry, air sampling, and real-time monitoring instruments.
- Working knowledge of cGMP requirements and pharmaceutical, biologics, biotechnology, or regulated manufacturing environments.
- Strong understanding of risk management methodologies and operational excellence principles.
- Ability to analyze complex technical issues and develop practical risk-based solutions.
- Strong leadership, project management, organizational, and influencing skills.
- Excellent written, verbal, and presentation communication skills.
- Proficiency with Microsoft Office applications and HSE management systems.
- Experience utilizing data analytics, performance metrics, and reporting tools to drive continuous improvement.
- Ability to work independently and effectively within cross-functional teams.
- Korean language proficiency is beneficial but not required.
Physical Demands
- Ability to sit, stand, walk, climb stairs and ladders, and traverse manufacturing, utility, warehouse, and office areas for extended periods.
- Ability to conduct field inspections, audits, risk assessments, and incident investigations in operating manufacturing environments.
- Ability to wear required personal protective equipment (PPE) and comply with site safety requirements.
- Ability to lift, carry, push, and pull up to 25 pounds occasionally.
- Ability to access confined or restricted industrial spaces, elevated work areas, and outdoor locations when required and in accordance with site safety procedures.
- Ability to respond to emergencies, incidents, and business-critical situations, including occasional after-hours support for a 24/7 manufacturing operation.
- Ability to travel between facilities and vendor or contractor locations as business needs require.
Work Environment
- This position operates in both office and manufacturing environments.
- Routine exposure to active production, utility, laboratory, warehouse, and construction areas should be expected.
- Position is based on a manufacturing campus and requires frequent presence in operational areas to support risk assessments, inspections, audits, investigations, and safety initiatives.
- Work may involve exposure to noise, moving mechanical equipment, chemicals, temperature variations, and other industrial conditions typical of pharmaceutical and biotechnology manufacturing facilities.
- Access to GMP and classified manufacturing areas is required and may necessitate the use of appropriate PPE, including safety glasses, hearing protection, safety footwear, hard hats, respirators, and other site-required protective equipment.
- Occasional work outside of normal business hours may be required to support incident response, project activities, shutdowns, or a 24/7 manufacturing operation.
Travel
Less than 5% travel is required for this position.
Target Bonus
10%
Work Location:
East Syracuse, NY
We are an Equal Employment Opportunity (“EEO”) Employer.
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!
Skills Required
- Bachelor’s degree in Environmental Health and Safety, Engineering, Industrial Hygiene, Chemistry, Biology, Occupational Health, or a related discipline
- 7+ years of experience in Process Safety, HSE, Operational Risk Management, or HSE program leadership
- Experience within pharmaceutical, biologics, biotechnology, chemical, or other highly regulated manufacturing environments
- Demonstrated success leading risk assessments, process safety initiatives, incident investigations, and regulatory compliance programs
- Experience supporting enterprise-wide process safety and operational risk initiatives across complex manufacturing operations
- Professional certification such as CSP, CIH, CCPSC, or equivalent credential
- Knowledge of Arc Flash hazards, electrical safety, and NFPA 70E compliance programs
- Strong knowledge of OSHA PSM, EPA RMP, NFPA standards, electrical safety, and LOTO requirements
- Experience conducting PHAs, HAZOPs, risk assessments, incident investigations, and MOC reviews
- Experience with ISO 45001 and maintaining a certified occupational health and safety management system
- Familiarity with industrial hygiene monitoring techniques, including noise dosimetry, air sampling, and real-time monitoring
- Working knowledge of cGMP requirements and regulated manufacturing environments
- Proficiency with Microsoft Office applications and HSE management systems
- Experience using data analytics, performance metrics, and reporting tools for continuous improvement
- Ability to work in manufacturing environments, access restricted or elevated areas, use PPE, and support occasional after-hours emergency response
What We Do
Headquartered in Seoul, South Korea, LOTTE BIOLOGICS was founded in 2022 with a mission to deliver therapies that contribute to a healthier world. At the Syracuse Bio Campus in New York, LOTTE BIOLOGICS provides high-quality GMP manufacturing services for drug substances. The facility offers a total production capacity of 40,000L, supported by eight 5,000L stainless steel bioreactors. Additionally, the campus includes extensive analytical QC testing laboratories and warehouse facilities that have received over 62 regulatory approvals from agencies worldwide. LOTTE BIOLOGICS is also advancing into a new area of expertise with Antibody-Drug Conjugates (ADCs) services. With over $100 million invested in ADC modalities, including both drug substance and conjugation capabilities on-site, we offer a seamless, end-to-end service from drug substance manufacturing to conjugation. Looking ahead, LOTTE BIOLOGICS is constructing three advanced bio plants in Songdo, South Korea. With construction of the first plant already underway and expected to be operational by 2027, each facility will feature eight 15,000L stainless steel bioreactors for large-scale commercial production, along with multiple 3,000L bioreactors to meet clinical production needs. Collectively, these plants will provide a manufacturing volume exceeding 360,000L in bioreactor capacity. Through our commitment to delivering innovative medicines to patients worldwide, LOTTE BIOLOGICS aims to become a top-tier global CDMO company in the biopharmaceutical industry.
