Principal Scientist, Commercial & Late-Stage Cell Culture Process Development
Denali Therapeutics
August 25, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
This position is responsible for driving upstream technical activities for commercial and late-stage process development for Denali’s commercial and near-commercial biologics portfolio.
Key Accountabilities / Core Job Responsibilities
- Serve as upstream cell culture technical lead for commercial manufacturing, including continued process verification, investigations, deviation support, and cross-site alignment.
- Support lifecycle management activities for commercial products: process improvements, tech transfer validation, local/cross-site change management, regulatory filing updates (CBE, PAS, Ex-US expansion), and responses to health authority questions.
- Drive technical continuity and alignment across CDMO and internal manufacturing sites by ensuring process understanding, lessons learned, and consistent capture/application of technical decisions.
- Design, oversee, and interpret small-scale process development studies to inform large-scale manufacturing, support root-cause investigations, and enable lifecycle improvements.
- Build/maintain technical risk assessments (e.g., FMEA) and process history files to support commercial manufacturing and future late-stage programs.
- Support late-stage process development pipeline and commercial programs via best practices, platform knowledge, and prior manufacturing experience while contributing to lifecycle management standardization.
Qualifications / Skills
- Typically requires a PhD in Biology, Biochemistry, Chemical Engineering, or related field, plus 10+ years of related experience.
- Strong experience with commercial process support, technology transfers, upstream cell culture characterization, and process validation.
- Experience managing post-approval changes as a technical SME with manufacturing, regulatory, supply chain, and quality.
- Experience reviewing batch records, supporting deviation investigations, and assessing process performance.
- Proven bioprocess leadership in cross-functional teams and working with CDMOs.
- Broad experience in process characterization, DoE, and analytics.
- Experience developing upstream cell culture processes for early/late-stage clinical production.
- In-depth knowledge of CHO-based fed-batch processes, scale-up/scale-down, and statistical tools.
- Excellent critical thinking, scientific problem-solving, and communication.
- Familiarity with BLA authoring and post-approval regulatory support (preferred).
Benefits / Application Instructions
- Salary range: $159,000.00 to $207,000.00; competitive total rewards package includes 401k, healthcare coverage, ESPP, and other benefits. Learn more at https://www.denalitherapeutics.com/careers.
Key Accountabilities / Core Job Responsibilities
- Serve as upstream cell culture technical lead for commercial manufacturing, including continued process verification, investigations, deviation support, and cross-site alignment.
- Support lifecycle management activities for commercial products: process improvements, tech transfer validation, local/cross-site change management, regulatory filing updates (CBE, PAS, Ex-US expansion), and responses to health authority questions.
- Drive technical continuity and alignment across CDMO and internal manufacturing sites by ensuring process understanding, lessons learned, and consistent capture/application of technical decisions.
- Design, oversee, and interpret small-scale process development studies to inform large-scale manufacturing, support root-cause investigations, and enable lifecycle improvements.
- Build/maintain technical risk assessments (e.g., FMEA) and process history files to support commercial manufacturing and future late-stage programs.
- Support late-stage process development pipeline and commercial programs via best practices, platform knowledge, and prior manufacturing experience while contributing to lifecycle management standardization.
Qualifications / Skills
- Typically requires a PhD in Biology, Biochemistry, Chemical Engineering, or related field, plus 10+ years of related experience.
- Strong experience with commercial process support, technology transfers, upstream cell culture characterization, and process validation.
- Experience managing post-approval changes as a technical SME with manufacturing, regulatory, supply chain, and quality.
- Experience reviewing batch records, supporting deviation investigations, and assessing process performance.
- Proven bioprocess leadership in cross-functional teams and working with CDMOs.
- Broad experience in process characterization, DoE, and analytics.
- Experience developing upstream cell culture processes for early/late-stage clinical production.
- In-depth knowledge of CHO-based fed-batch processes, scale-up/scale-down, and statistical tools.
- Excellent critical thinking, scientific problem-solving, and communication.
- Familiarity with BLA authoring and post-approval regulatory support (preferred).
Benefits / Application Instructions
- Salary range: $159,000.00 to $207,000.00; competitive total rewards package includes 401k, healthcare coverage, ESPP, and other benefits. Learn more at https://www.denalitherapeutics.com/careers.