cGMP Sr. Biomanufacturing Specialist - (#339)

Job Description

FUJIFILM Cellular Dynamics, Inc in Madison, WI is recruiting for a SeniorcGMPbio-manufacturing specialists Thisroleprovideoutstanding opportunitiesfor experienced andtalented self-motivated individuals, with a minimum of three years of relevant cGMP manufacturing or processing experienceideallywith(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 usingcutting edge iPSC technology.

1. Perform laboratory work in a cGMPsetting, 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. Draft, review and approve SOP’s, manufacturing procedures, and other document types as required.
4. Maintain high level of product and process quality standards and demonstrate ownership for continuous improvement – recommending improvements as applicable.
5. Compile and analyze in-process data to identify trends and key process parameters to troubleshoot and resolve trends in 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 plus five years of relevant work experience.·
• Three years of directly applicable cGMP manufacturing and/or processing experience, with demonstrated achievements and progressive responsibilities.
• 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.