Principal Scientist - Process Development, Upstream
About The Position
The Principal Scientist - Process Development, Upstream is responsible for the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures that can be successfully transferred to cGMP manufacturing to generate therapeutic proteins for clinical trials. This role will lead and execute complex process development activities including seed train scale-up, bioreactor operations, and process optimization using Design of Experiments (DoE), while supporting tech transfer to manufacturing. The individual will operate as a technical lead across multiple projects, collaborating cross-functionally and with external clients to ensure robust, scalable processes and successful delivery across early-phase through late-stage development programs.
Requirements
- Ph.D. in Biotechnology or related field with 8–10 years of laboratory experience, OR MS with 12+ years, OR BS with 15+ years of industry experience
- Experience in development and implementation of upstream process development methodologies, including mammalian cell culture and bioreactor operations
- Hands-on experience with process development, scale-up, and transfer of processes to cGMP manufacturing
- Strong knowledge of Design of Experiments (DoE), process optimization, and process parameter definition
- Experience working in a cGMP environment and applying good documentation practices (GDP)
- Ability to independently design, execute, and analyze experiments, interpret complex data, and provide insight into potential issues and solutions
- Ability to troubleshoot and problem solve complex process issues, analyze data, and initiate and execute corrective actions
- Strong technical writing skills with experience authoring SOPs, batch records, protocols, and technical reports
- Ability to lead multiple complex projects, communicate effectively with internal and external clients, and provide technical leadership and mentorship
Responsibilities
- Lead the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures for transfer to cGMP manufacturing
- Troubleshoot and problem solve process issues, initiate and execute corrective actions, and monitor outcomes to ensure successful project completion
- Design and execute process development experiments including seed train scale-up, bioreactor inoculation, and production operations
- Apply Design of Experiments (DoE) for clone screening, process optimization, and defining process parameters and operating conditions
- Support tech transfer activities to manufacturing, ensuring processes are robust and can be successfully transferred to cGMP manufacturing
- Lead multiple complex projects at a time and serve as a technical lead providing scientific consultation and direction
- Analyze and interpret complex data, integrate experimental results with project objectives, and provide insight into potential issues and solutions
- Collaborate with internal functional areas and external clients to communicate project status and ensure delivery of high-quality processes
Benefits
- Competitive medical benefits
- 401K
- 152 hours PTO
- 8 Paid Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
