Responsible for the operation of mammalian cell culture production processes in compliance with cGMP regulations.
Prepares, assembles, pressure holds, SIP, and sterility test 50L to 2500L bioreactors.
Supervises preparation of buffers and supplements for production.
Supervises/Performs daily monitoring of process.
Maintains production batch records and documentation. Revises batch records and SOPs as necessary.
Carries out large-scale cell culture harvest.
Supervises post production cleaning of equipment.
Trains operators to use the bioreactors and related process equipment in accordance with the cell culture personnel training procedure and related SOPs.
Minimal work on weekends and/or holidays may be required.
Carries out direct supervisory responsibilities in accordance with the department-set goals.
Bachelor’s degree in chemical/biochemical engineering or related discipline with at least 5-7 years of hands-on experience in cGMP industry.
Master’s degree preferred.
Must possess strong communication (oral and written), organizational, interpersonal, and leadership skills, have an aptitude for troubleshooting, with the ability to perform independently and in a team environment.
Must be detail oriented, adept at using hand tools, with excellent aseptic techniques, knowledge of cGMP cell culture production, regulations and conditions, demonstrated ability in documentation, and be able to follow SOPs as required.