Responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean-room, retain records and write reports. May also be responsible for troubleshooting.
Bachelor’s degree and 0+ years’ experience; or Associate's degree (A. A.) or equivalent from two-year college or technical school and at least one year of equivalent experience; or equivalent combination of education and experience.
- Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities.
- Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification.
- Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.
- Read and follow equipment diagrams used in biotech manufacturing.
- Perform operations in process control system.
- Follow procedures needed to support CGMP activities.
- Perform pH and conductivity measurements and filter integrity testing.
- Clean and sterilize processing equipment using automated or manual systems.
- Complete successful gowning qualification and flow procedures for clean rooms.
- 7pm-7am , 2-2-3 schedule, nights
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.