Principal Scientist, Commercial and Late-Stage Purification Process Development
Denali Therapeutics
August 26, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Key Accountabilities / Core Job Responsibilities:
- Serve as downstream purification 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 and 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 capturing and applying process understanding, lessons learned, and 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 and maintain technical risk assessments (e.g., FMEA) and process history files for robust commercial manufacturing and future late-stage programs.
- Support late-stage process development pipeline and commercial programs using best practices, platform knowledge, and prior manufacturing experience to standardize lifecycle management.
Qualifications / Skills:
- PhD in Biology, Biochemistry, Chemical Engineering, or related field plus 10+ years relevant experience.
- Strong experience in commercial process support/technology transfer, downstream purification characterization, and process validation.
- Experience managing post-approval changes as a technical SME with site, regulatory, supply chain, and quality.
- Experience reviewing batch records, deviation investigations, and process performance assessment.
- Proven bioprocess technical leadership in cross-functional teams and with CDMOs.
- Broad experience in process characterization, design of experiments, and analytics.
- Downstream purification process development for early- or late-stage clinical production.
- Expertise in AKTA protein purification systems, antibody characterization methods, and other biophysical techniques.
- Excellent critical thinking, problem-solving, and communication skills.
- Preferred: familiarity with BLA authoring and post-approval regulatory support.
Benefits (as stated): 401k, healthcare coverage, ESPP, and other benefits.
Application: Learn more at https://www.denalitherapeutics.com/careers
- Serve as downstream purification 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 and 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 capturing and applying process understanding, lessons learned, and 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 and maintain technical risk assessments (e.g., FMEA) and process history files for robust commercial manufacturing and future late-stage programs.
- Support late-stage process development pipeline and commercial programs using best practices, platform knowledge, and prior manufacturing experience to standardize lifecycle management.
Qualifications / Skills:
- PhD in Biology, Biochemistry, Chemical Engineering, or related field plus 10+ years relevant experience.
- Strong experience in commercial process support/technology transfer, downstream purification characterization, and process validation.
- Experience managing post-approval changes as a technical SME with site, regulatory, supply chain, and quality.
- Experience reviewing batch records, deviation investigations, and process performance assessment.
- Proven bioprocess technical leadership in cross-functional teams and with CDMOs.
- Broad experience in process characterization, design of experiments, and analytics.
- Downstream purification process development for early- or late-stage clinical production.
- Expertise in AKTA protein purification systems, antibody characterization methods, and other biophysical techniques.
- Excellent critical thinking, problem-solving, and communication skills.
- Preferred: familiarity with BLA authoring and post-approval regulatory support.
Benefits (as stated): 401k, healthcare coverage, ESPP, and other benefits.
Application: Learn more at https://www.denalitherapeutics.com/careers