Support and assist in the necessary operations required for the fermentation and upstream separations necessary for the production of proprietary biotheraputic and immunizing agents under cGMP cell culture and microbial fermentation through to the crude intermediate stage. Uses aseptic technique to maintain pure cell cultures, operates a fermenter and centrifuges to grow and harvest cell cultures and uses filtration methods (tangential flow and dead end) to support MAB manufacturing. Follow all GMP documentation to ensure materials have followed procedures outlined in batch records and Standard Operating Procedures. Ensure proper maintenance and operation and cleaning of equipment.
Skilled in processing of mamalian cell fermentation, aseptic technique, and large scale chromatography and cGMP. Electromechanical aptitude and technical writing skills requied as well as proficiency in computer software applications.
Bachelor's degree in a life science such as Microbiology, Biology. Five plus years experience in this area in a medium to large organization.
Biotest Pharmaceuticals - 2 years ago