Process Development Engineer
- Thousand Oaks, CA
- Permanent
- Full-time
The ideal candidate will be a Process Development Engineer with a strong foundation in upstream biologics, including suspension cell culture, bioreactor operations, and monoclonal antibody production. The engineer will join the Drug Substance Technology Engineering team, supporting the development and manufacturing of human therapeutic products from clinical stages through commercial production. They will apply process engineering knowledge to support technology transfer and manufacturing in an advanced suite utilizing single-use technology.Responsibilities:
- Transfer cell culture processes for drug substance manufacturing and performs process improvements from the laboratory into the manufacturing facility
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
- Offer process validation support for late stage commercial processes
- Provide routine process monitoring and troubleshooting
- Execute data trending and statistical process analysis
- Support technical direction for process related deviations, CAPAs and change controls
- Identify and support process related operational excellence opportunities
- Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory
- Staff will support all upstream processes (clinical and commercial) executed in the facility, performing process monitoring and responding to issues as appropriate. In addition, staff will perform and/or support tech transfer of early clinical candidate molecules.
- Master’s Degree in Chemical or Biochemical Engineering
- 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
- Background in biologics tech transfer into commercial facilities
- Cell culture process knowledge: Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
- Strong capability of analysis, troubleshooting and problem solving
- Ability to develop and follow detailed protocols
- Independently motivated with ability to multi-task and work in teams
- Excellent written and verbal communication skills with technical writing and presentation experience
- Must have at-scale biologics cell culture experience (manufacturing experience, engineering/equipment experience)
- Strong understanding of data analysis tools (JMP preferred)
- Excellent communication and troubleshooting (Must be comfortable presenting data & technical information to a group of 20+ people. Presenting at min once per month to quarter)
- Knowledge of cell culture processes/ equipment; scale up factors from mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes.
- GMP experience is a huge plus - someone who has dealt with regulatory inspectors/auditors (FDA, other regulatory agencies from other countries)
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