cGMP Biomanufacturing Specialist - (#341)

  • 465 Science Dr, Madison, WI 53711, USA
  • Full-time

Company Description

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

Job Description

FUJIFILM Cellular Dynamics, Inc in Madison, WI is recruiting for a cGMP bio-manufacturing specialist This role provide outstanding opportunities for talented self-motivated individuals, ideally with experience in (stem) cell biology, immunology, and/or molecular biology, who can contribute to our ongoing efforts to generate differentiated cell types from human induced pluripotent stem cells.   We are most interested in connecting with qualified individuals who aspire to support the development of therapeutics and/or life science products and tools to support research endeavors.  In return we provide development and support to enhance your career using cutting edge iPSC technology.

Essential Job Functions

  1. Perform laboratory work in a cGMP setting, primarily working with iPS cell culture and differentiation, following bio-manufacturing procedures and manufacturing schedules to facilitate on-time delivery of high-quality finished products.
  2. Maintain laboratory standards to include but not limited to monitoring status, routine maintenance, and raw material inventories using ERP system.
  3. Recommend and update bio-manufacturing procedures, as required.
  4.  Maintain high level of product and process quality standards and demonstrate ownership for continuous improvement – recommending improvements as applicable.  
  5. Analyze in-process and QC data to identify trends and key process parameters to troubleshoot and resolve trends in bio-manufacturing processes.
  6. Identify and implement cost-reduction opportunities.
  7. Maintain a safe and compliant work environment.
  8. Understand and comply with ethical, legal and regulatory requirements applicable to FUJIFILM Cellular Dynamics, Inc. business.
  9. Compile and analyze data as requested and assist in implementation activities to include process changes and corrective actions.
  10. Participate on technical transfer teams.
  11.  Other job functions as assigned.

Qualifications

  • Bachelor’s degree in cell biology, molecular biology, biochemistry or related technical field
  • Or an associate degree in a comparable field of study with an additional two years of relevant work experience.
  • Demonstrated ability to perform the following:
  • Work in laboratory hood for extended periods of time to including repetitive hand motion.
  • Comfort working with clearly labeled hazardous materials – following all safe handling procedures.
  • Work at computer for extended periods of time.
  • Wear cGMP laboratory personal protective equipment
  •  Occasionally lift 50 pounds

Additional Information

 

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.