FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell products and donor-specific MyCell Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development
In this new role you will lead the development of environmental, health and safety systems, policies and procedures, employee training, programs, and internal marketing. We are currently in construction of a new cGMP facility to enable new business opportunities and support our existing development efforts. The role will be essential in developing a culture of safety and risk management for all our facilities in Madison, WI to include validating our new facility. You will be supported by an active group of passionate employees as well as the corporate resources from Fujifilms North American Holdings group.
While many programs are in place and evolving this role requires an individual with passion for building programs, ability to influence at all levels, and has perspective operating in a commercial bio-tech environment.
- Lead efforts to create, review, and revise safety-related policies and procedures at FCDI to ensure safe work practices are in place.
- Perform EHS and biological risk/hazard assessments for new and existing operations to assist in developing safe work practices and maintaining compliance.
- Assist in the review of new laboratory projects to ensure controls are in place to maintain safety and compliance.
- Manage the employee safety training program: identify required training based on job tasks and responsibilities, ensure training assignment and documentation of training and compliance on an ongoing basis - ensure EHS and biological safety policies and procedures are in place and followed.
- Conduct and/or host regular laboratory inspections to ensure compliance with biological safety, and to ensure laboratory safety best practices are followed, i.e., proper chemical storage, waste accumulation and storage, PPE, emergency response equipment, etc.
- Organize and chair EHS and Biological Safety Committee at FCDI.
- Ensure procedures are in place, up-to-date, and followed for chemical storage, handling and disposal.
- Maintain site chemical inventory/ SDS library.
- Support the development and implementation of waste management protocols for laboratory operations and ensure adherence to procedures.
- Assist with Occupational Health Program & Medical Surveillance program documentation
- Act as Biosafety Officer, Chemical Hygiene Officer/ TSCA representative for the site.
- Develop and maintain all facility emergency plans and conduct biannual evacuation drills.
- Assist in documenting incidents, root cause analysis investigations, corrective and preventive actions.
- BA/BS degree in a related field (science or engineering preferred)
- 5 years of experience in EHS for biotech/pharma industry with demonstrated proficiency and increasing levels of accountability.
- Experience with industry compliance/ regulatory concepts and EHS best practices for bio-safety, chemical hygiene and the control of toxic and hazardous substances
- Knowledge of applicable laws, professional standards, biological safety and physical containment
- Expertise in assessment and communication of risk to personnel, the community, and the environment
- Well-rounded and effective communication skills
FUJIFILM Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.