Principal Scientist, Commercial & Late-Stage Cell Culture Process Development
$159,000–$207,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Lead upstream cell culture technical activities for commercial and late-stage process development, including continued process verification, deviation support, and cross-site alignment. Manage lifecycle activities for biologics portfolio, overseeing process improvements, tech transfer validation, regulatory filing updates, and health authority responses. Design small-scale process development studies to inform large-scale manufacturing decisions while supporting root-cause investigations and lifecycle improvements. Build and maintain technical risk assessments and process history files to ensure robust commercial manufacturing. Drive technical continuity across CDMO and internal sites, ensuring process understanding and consistent application of lessons learned. Apply best practices and platform knowledge to support the incoming late-stage pipeline and standardize lifecycle management practices.
Required Qualifications
- PhD in Biology, Biochemistry, Chemical Engineering or related scientific discipline
- 10+ years of related work experience
- Strong experience with commercial process support and technology transfers
- Strong experience with upstream cell culture characterization
- Strong experience with process validation
- Experience managing post-approval changes as a technical SME in collaboration with manufacturing site, regulatory, supply chain and quality
- Experience reviewing batch records
- Experience supporting deviation investigations
- Experience assessing process performance during manufacturing campaigns
- Proven track record of representing bioprocess functions in cross-functional teams
- Proven track record of working effectively with CDMOs
- Broad experience in process characterization
- Broad experience in design of experiments
- Broad experience in analytics
- Experience developing upstream cell culture processes to support early or late-stage clinical production
- In-depth understanding of CHO-based fed-batch processes
- In-depth understanding of scale-up/scale-down principles
- In-depth understanding of statistical tools
- Excellent critical thinking
- Excellent scientific problem-solving
- Excellent communication skills
Desired Qualifications
- Familiarity with BLA authoring
- Familiarity with post-approval regulatory support
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