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

We are recruiting for a Quality Control Analyst – II – Therapeutics to support our continued growth and on-going development projects.  Qualified individuals need have the capability, and to be inspired to support the development of therapeutics (cGMP) products and tools to support research endeavors.  We aspire to improve the quality of life through our efforts.  In return we provide development and support to enhance your career using cutting edge iPSC technology. 

In this highly critical and visible role you'll provide quality control services and support quality initiatives, ensuring implementation of Quality Management Systems, and compliance with applicable product performance standards and guidelines.  If you aspire to be a key influencer in creating and maintaining a culture of quality, compliance, and cost initiatives, we offer an exceptional and unique opportunity to fully develop your career potential.

In this role you will be responsible for the following:

Essential Job Functions

1. Qualify Quality Control (QC) finished product test methods to support cell therapy programs.
2. Liaise with project teams to perform technology transfer for QC test methods and cell characterization assays.
3. Perform QC testing on cell therapeutics intended for pre-clinical animal studies and human clinical trials.
4. Work with project teams to establish reference standard materials to support cell therapy programs.
5. Perform studies to qualify and validate QC test methods to support cell therapy production for pre-clinical animal studies and human clinical trials.
6. Draft and execute product stability protocols.
7. Write/review/revise SOPs related to quality control testing including test methods, equipment use, maintenance and calibration.
8. Assist in equipment qualification activities, as required.
9. Support QC functions for cleanroom operations including review and tracking of environmental monitoring data and cleanroom maintenance practices.
10. Assist in the ordering of lab supplies and maintenance of lab equipment, as required.
11. Strictly adhere to SOPs and Good Documentation Practices
12. Perform technical reviews of raw data prior to audit by Quality Assurance.
13. Document laboratory deviations and investigations with minimal supervision.
14. Lead and support CAPA and continuous improvement initiatives.
15. Other job functions as assigned.

• Bachelor’s degree in a life science discipline such as but not limited to cell biology, biochemistry, or microbiology
• 3 years of relevant quality control experience to include test method development in flow cytometry and qPCR, with demonstrated achievements and progressive responsibilities.
• Experience and demonstrated performance in a GMP lab.
• Demonstrated proficiency in performing necessary audits – with supplier quality auditing experience highly desirable.
• Demonstrated organizational; problem solving; decision-making; communication (oral and written); and influencing skills – dealing with diverse stakeholders.
• Proficiency with MS office suite of products
• Ability to perform basic scientific math
• Ability to perform basic scientific math
• Experience with Good Documentation Practices
• Functional proficiency with an eQMS solution
• Able to work at computer for extended periods of time
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Able to work in cleanroom environment for extended periods of time.
• Able to work with hazardous materials (i.e. chemicals, electrical equipment and human tissue) without endangering oneself or others.
• Able to wear standard laboratory PPE

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.