With an extensive offering of development services, state-of-the-art manufacturing equipment, and project support, we are truly a full-service CDMO biologics partner. Our approach pairs our expert knowledge base with an open mind towards scientific discovery so that together we can develop an optimal way to make our systems work for you and your biologics project, no matter how complex it may be.
Reporting to the Upstream Manufacturing Manager, you will be responsible for supporting the overall Upstream GMP process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II/III and commercial GMP manufacturing. Main responsibilities include:
- Operation of pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use and stainless-steel bioreactors, single use mixers, depth filtration skids, TFF skids, chromatography skids and in process testing equipment.
- Execution of all Upstream Clinical Manufacturing and Development operations, including but not limited to work functions in cell culture, cell banking, media optimization, seed train preparation, bioreactor operations, harvest/clarification, and technology transfer to manufacturing.
- Perform and monitor critical processes, execute manufacturing batch records (MBR), develop SOPs and protocols. Provide audit support.
The ideal candidate will have:
- A BS Degree in Science, Engineering or related field
- 2-4 years experience with biologic production processes under GMP
- Upstream processing experience is preferred
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