Scientist - Process Development (USP/DSP)

📍 Location: Vacaville, California

Overview
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.

Key Responsibilities

Laboratory Execution & Study Leadership

• 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

Protocol, Reporting & Data Analysis

• 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

Lab Operations & Compliance

• 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

Cross‑Functional & Customer Support

• 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

Group‑Specific Focus Areas

Upstream (USP):

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

Downstream (DSP):

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

Qualifications

• 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