Our client is searching for an Upstream Tech Transfer Lead. This individual will be responsible for transfer and support assigned project(s) to CMO(s) as upstream tech transfer representative including fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support and deviation write ups, process validation documentation review/approval, campaign summary report authoring, and routine presentations to cross-functional teams and management.
- Hands on cell culture experience with stirred tank bioreactors (Stainless or single use)
- Cell culture tech transfer and/or development experience
- Hands on or tech transfer experience to at least 200L scale or above
- Fundamental understanding of upstream unit operations such as mixing, bioreactor, and filtration.
- Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes
- Knowledge of GMP manufacturing principles and documentation
- Skilled in root cause analysis and problem-solving
- Skilled in effectively explaining complex scientific or engineering concepts to a broad and diverse cross-functional audience.
Remote: Upstream Tech Transfer Lead (229581)