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.

For more information, please visit our website at www.kincellbio.com.

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

<25%
Required to travel to alternate sites at least once a quarter

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.

Kincell Bio

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