Scientist/Senior Scientist Cell Culture Antibody Manufacturing
FibroGen seeks a Scientist/Senior Scientist to support the manufacture of cell culture antibody production at Contract Manufacturing Organizations and to design and execute process characterization studies for mammalian (CHO) based processes both at Fibrogen as well at as contract laboratories.
- Support operation and maintenance of lab equipment including Ambr 250 mL Benchtop Bioreactor system, 2L and 10L Applicon bioreactors system, and BioProfile Flex cell culture analyzer
- Aid and lead both internal and external process characterization and process optimization activities both at Fibrogen as well at as contract laboratories. Up to 50% of time will be for lab support
- Support Technology Transfer activities to CMOs including: support for process validation, process performance qualification, deviation resolution and facilitate the batch disposition process with Quality Assurance for upstream operations
- Provide input on Process Description updates and Change Control Requests related to equipment, process and facility changes at CMOs
- Author and review relevant sections in regulatory filings and lead response to questions for
- Bachelors with 6-10 years, Masters with 4-8 years, or Ph.D with 2-4 years in cell biology, genetics or other related scientific discipline
- A minimum of 3 years experience in process development, process engineering and manufacturing environments
- Experience with monoclonal antibody upstream processes including fed batch and perfusion.
- Prior experience with Upstream Process Characterization, Process performance qualification and Commercial Manufacturing activities for a biologic product
- In-depth experience with mammalian cell culture including strong aseptic technique and experience with lab 2L minifermenters. Preference for additional experience with Nova Flex systems and Ambr 250mL Benchtop bioreactors
- Working knowledge of GMP regulations and guidelines
- Highly preferred traits of effective interpersonal and communication skills. Desire to take initiative and accountability as well as possessing high levels of self-direction