Kincell is a technology-forward contract development and manufacturing organization (CDMO) that streamlines analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing.
Our focus is on developing and manufacturing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs.
For more information, please visit our website at www.kincellbio.com.
Kincell Bio is seeking a highly motivated EH&S Specialist II who will be a key contributor to a dynamic and collaborative Engineering team. The EH&S Specialist II will be responsible for the development and/or oversight of all company safety operations concerning fire, emergency, safety, and environmental programs at the Kincell Bio facilities in Raleigh, NC and Gainesville FL. The EH&S Specialist II is also responsible for all safety policies, including all federal, state, and local regulations and codes. The role will execute the day-to-day activities of the site safety and environmental health strategy and policy. In addition, assist in execution of the engineering strategy commensurate with the overall site plan as outlined by the Senior Director of Engineering and Kincell Bio.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
- 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 (2) 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
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
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, particularly in the following key areas: Environment (ex. waste management, lab safety, energy efficiency, and sustainability) & EHS management systems.
- 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.
- Proven ability to quickly assess situations through demonstrated problem-solving skills and knowledge of state-of the-art technology related to their EHS discipline.
- Works well in a team environment.
- 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
Location
- This position is 100% on-site in Raleigh, North Carolina, with quarterly trips to Gainesville, FL.
#LI-Onsite
Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.
