Process Development Scientist III

Scientist - Process Development (USP/DSP)

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Location:

Vacaville, California

We are seeking an experienced Process Development Scientist to support Cell Culture Development (USP) and Purification Development (DSP) activities. This individual will execute laboratory studies with a high degree of autonomy and serve as a subject matter expert across multiple aspects of process development. The role may also support Analytical Development activities as needed.

This position offers the opportunity to act as a Study Director, contribute to experimental design, and provide technical leadership within a collaborative MSAT/Process Development environment.

• Execute routine and non‑routine laboratory studies in accordance with SOPs and GLP/GMP requirements
• Serve as Study Director for laboratory studies
• Design and execute experiments using Design of Experiments (DOE) principles
• Perform root cause analysis (RCA) and support process characterization studies

• Author and review study protocols and technical reports
• Serve as a final reviewer for protocols and reports
• Perform advanced data analysis using site‑standard software
• Interpret results, draw conclusions, and communicate study outcomes
• Prepare and present study data to internal teams with minimal guidance

• Review and maintain laboratory documentation
• Support preventative maintenance and lab housekeeping activities
• Participate in safety audits, 6S activities, and document ownership
• Ensure training records remain current and compliant

• Represent the Process Development/MSAT lab on internal and external project teams
• Provide updates to global project teams and participate in customer discussions
• Support customer and regulatory audits as needed

• Mammalian cell culture, scale‑down models, satellite runs
• Bioreactor operations, harvest hold studies, cell culture separation
• Mass transfer, centrifugation, filtration, and process characterization

• Chromatography (AKTA systems), UF/DF, virus filtration
• Buffer preparation, column packing, scale‑down models
• Protein purification and process characterization

• Bachelor's degree required (Biology, Biochemistry, Chemical Engineering, or related field)
• Hands‑on laboratory bench experience with GLP/GMP practices
• Experience in process development and scale‑up/manufacturing support
• Strong understanding of cell biology and bioprocessing principles
• Experience with USP and/or DSP operations preferred
• Ability to work independently while providing technical guidance to junior scientists

Impellam Group and its brands are equal‑opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre‑employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR‑ or fill out this form to request accommodations.