Late-Stage Upstream Process Development Lead

Cedent; San Francisco (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading biotech company in San Francisco is searching for a Principal Scientist to lead late-stage upstream cell culture process development for large molecule programs. This role requires a PhD with at least 7 years of biotech experience in process development and regulatory compliance. The ideal candidate will manage scale-up and tech transfer activities, ensuring successful collaboration across various teams. Candidates should have excellent communication skills and a strong understanding of regulatory expectations for process validation.

Qualifications

• Minimum 7 years of cell culture process development experience in biotech/biopharma.
• In-depth understanding of CHO-based fed-batch processes.
• Experience with late-stage upstream process development and BLA authoring.

Responsibilities

• Lead scale-up and tech transfer of upstream processes to manufacturing.
• Collaborate with cross-functional teams for process performance qualification.
• Author and review relevant CMC documentation.

Skills

Cell culture process development

Technical writing

Leadership

Cross-functional collaboration

Statistical tools

Education

PhD in biology, biochemistry or related field

BS/MS with 12+ years of experience

Job description

A leading biotech company in San Francisco is searching for a Principal Scientist to lead late-stage upstream cell culture process development for large molecule programs. This role requires a PhD with at least 7 years of biotech experience in process development and regulatory compliance. The ideal candidate will manage scale-up and tech transfer activities, ensuring successful collaboration across various teams. Candidates should have excellent communication skills and a strong understanding of regulatory expectations for process validation.