Environmental Health and Safety Specialist II in Durham

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

Essential Duties and Responsibilities

• Responsible for developing and deploying Environmental Health & Safety programs & policies to mitigate risk, drive regulatory compliance and promote a positive EHS culture.
• Compliance with GMP/GDP/FDA/EH&S requirements and regulations.
• Identify, monitor, and own key EHS performance indicators.
• Use data to develop strategies to improve site safety and reduce environmental impact.
• Reinforce and sustain safety-first culture.
• Ownership of EHS component for existing facilities and involvement in construction of future facilities.
• Participation in project meetings, anticipate outcome of decisions and monitor site construction activities.
• Provide technical expertise and guidance to solve site hazards (chemical, biological, physical, electrical, slip/trip/fall, confined space, ergonomic, etc.).
• Lead EHS compliance and program audits of the manufacturing site and service operations.
• Provide follow-up and support post audits to ensure execution to action plan, risk mitigation & program improvements.
• Evaluate facility EHS conditions, assess risks and develop appropriate corrective-action plans and budgets to address deficiencies in comparison to regulations and internal policy/protocol.
• Provide EHS guidance and compliance support to site managers in addressing government inquiries, violations and to ensure compliance with program requirements.
• Leads accident response, reporting, and corrective actions.
• Independently manages the good catch program.
• Independently manages the first aid training program.
• Independently manages the bloodborne pathogen program.
• Independently manages the HEP-B program.
• Provides guidance for best Laboratory safety practices.
• Provides guidance for best Manufacturing safety practices.
• Coordinates and leads multi-discipline Site Safety Team.
• Independently manages the sites EHS policies, procedures and programs.
• Independently manages the sites safety shoe and glasses programs.
• Manages multiple sites permits pertaining to EHS (Biosafety Permit, Fire Permit, Hazardous Waste, Etc.).
• Oversight (Administrator) of the Alert Media notification program.
• Manages EHS budget with Engineering Lead.
• Attends and actively participates in cross functional meetings to ensure EHS/ENG site- and company-wide deliverables are met.
• Other duties as assigned.

Qualifications

Required:

• Associate’s degree in occupational / industrial safety, industrial hygiene, environmental science or in a physical science with 2 years of progressive EH&S experience.
• Bachelor’s degree in occupational / industrial safety, industrial hygiene, environmental science or in a physical science with 2 years of progressive EH&S experience.
• Minimum of three years of related experience in mixed use (office, manufacturing, and lab) environment required.
• An equivalent combination of education and experience may be considered.
• Knowledge and experience with Confined Space Entry, LOTO implementation/training, respirator implementation/training and health programs.
• Demonstrated understanding of key regulatory requirements (e.g. Hazmat/RCRA, NFPA and OSHA rules and regulations) and their application to a laboratory and manufacturing environment.
• Comprehensive knowledge of technical specialty, applicable laws, applicable licensure, applicable permitting, regulations, and guidelines related to area of expertise.
• Skilled in the standards, concepts, practices, and procedures within the health, safety, and environmental fields.
• Proven ability to quickly assess situations through demonstrated problem-solving skills and knowledge of state-of-the-art technology related to their EHS discipline.
• Computer software skills, organization, record keeping and planning.
• Must have excellent communication skills and ability to work in a team-oriented environment.
• The individual must be capable of independent work required.
• Business setting and acumen required.
• Flexible, proficient in technical writing, strong interpersonal and communication skills required.
• Strong knowledge of current industry trends and the ability to use the latest technologies is beneficial.

Preferred:

• Bachelor’s degree in occupational / industrial safety, industrial hygiene, environmental science or in a physical science, with 5 years of progressive EH&S experience.
• An equivalent combination of education and experience may be considered.
• Experience in Safety, Industrial Hygiene, Environmental Sciences or related field preferred.
• Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products as they pertain to EH&S is beneficial.

Physical Demands

Adjusting or moving objects weighing up to 25lbs.

Travel Requirements

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Location

This position is 100% on-site in Raleigh, North Carolina, with quarterly trips to Gainesville, FL.