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

FUJIFILM Cellular Dynamics, Inc in Madison, WI is recruiting for the newly created role of Technical Transfer Specialist.   Qualified individuals need to be inspired to support the development of therapeutics and/or life science 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 role you'll support the efficient transfer of manufacturing and quality control processes from Development to Operations throughout the lifecycle of a product.  Prepare tech transfer documentation including material, equipment, and process specifications.  Proactively collect information from subject matter experts in R&D and at vendors and prepare the documentation required to start manufacturing and QC operations.  This is primarily a non-laboratory position though occasional work in a laboratory or manufacturing setting may be required.

 Essential Job Functions

1. Support smooth and efficient tech transfer of processes and analytical methods from development groups or clients to FCDI operations.
2. Work with internal and external subject matter experts to gather technical information about materials, equipment, and processes; capture on the appropriate forms and reports to enable implementation in operations.  
3. Work with cross-functional teams to track action items and ensure timely completion of all tech transfer enabling activities. 
4. Support project leads and project management by tracking and reporting progress on GMP readiness and tech transfer document completion.
5. Assist in the preparation of user requirements, material specifications, system impact assessments, and process specifications.
6. Support investigations and continuous improvement project related to materials, equipment and processes.
7. Other job functions as assigned.

• Bachelor’s degree, in life sciences, chemistry, engineering, or related field, or Associates degree plus two years relevant work experience. 
• Two years of relevant work experience in biomanufacturing or quality assurance, with demonstrated achievements and progressive responsibilities.
• Strong organizational and communication skills.
• Self-motivated with a sound work ethic, initiative, and the ability to multi-task.
• Flexibility to change project objectives quickly and enthusiastically.
• Proficient in written and oral communication, as well as the ability to work well independently and as part of a team.
• Fundamental knowledge of the manufacturing environment for cell therapies or other biologics.
• Functional knowledge of analytical (QC) procedures for cell therapies or other biologics.
• Familiarity with biologics manufacturing equipment and materials.
• Awareness of Good Documentation Practices.
• Baseline proficiency with Microsoft Excel, Word, and PowerPoint.
• Some evening and/or weekend work is required.
• 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.