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Sr. Manufacturing Associate I/II-Downstream (days)
Durham, NC
Job Description
Position Summary:
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 writereports. May also be responsible for troubleshooting.Position Description:
- 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 forclean rooms.
- 7pm-7am , 2-2-3 schedule, days
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 veteran status, are strongly encouraged to apply.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
1+ years
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