Overview In this role you lead the development and transfer of mammalian cell culture upstream processes to cGMP manufacturing, shaping robust, scalable production for clinical programs. You will oversee seed-train scale-up, bioreactor operations, and DoE-driven optimization, coordinating tech transfer and cross-functional collaboration. You drive complex projects with scientific leadership, delivering high-quality processes across early to late-stage development. This position offers impact on drug development programs within a fast-paced, innovation-focused environment.
Compensation / Benefits- Competitive medical benefits
- 401K
- 152 hours PTO
- 8 Paid Holidays
- Dynamic, fast-paced work environment
- Continuous Improvement Processes
Responsibilities- Lead development and implementation of mammalian cell culture upstream processing methodologies for transfer to cGMP manufacturing
- Troubleshoot process issues, implement corrective actions, monitor outcomes
- Design and execute process development experiments including seed-train scale-up, bioreactor inoculation, and production operations
- Apply DoE for clone screening, process optimization, and defining process parameters
- Support tech transfer activities to manufacturing ensuring robust transfer to cGMP manufacturing
- Lead multiple complex projects providing scientific consultation and direction
- Analyze data, integrate results with project objectives, and offer solutions
- Collaborate with internal and external stakeholders to communicate status and ensure delivery of high-quality processes
Key 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 upstream process development methodologies including mammalian cell culture and bioreactor operations
- Hands-on experience with process development, scale-up, and transfer to cGMP manufacturing
- Strong knowledge of DoE, process optimization, and parameter definition
- Experience in a cGMP environment and GDP
- Ability to design, execute, and analyze experiments and interpret complex data
- Ability to troubleshoot complex process issues and initiate corrective actions
- Strong technical writing skills for SOPs, batch records, protocols, and reports
- Ability to lead multiple projects, communicate with clients, and provide technical leadership and mentorship
- leadership
- cross-functional collaboration
- effective communication
- mammalian cell culture
- bioreactor operations
- Design of Experiments (DoE)
