Principal Scientist, Purification Process Development
Denali Therapeutics
August 22, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Key Accountabilities / Core Job Responsibilities
- Independently lead purification/downstream process characterization, tech transfer, and late-stage activities.
- Author protocols; coordinate study execution; review analytical results; generate/review reports; author IND/BLA sections.
- Coordinate internal team to generate late-stage process characterization/validation data packages.
- Support selection/coordination of CDMOs to generate high-quality late-stage data packages.
- Transfer purification processes to CMOs and support ongoing manufacturing as needed.
- Support other late-stage projects and apply lessons learned.
- Design and execute lab-scale chromatography and filtration studies to inform large-scale decisions.
- Maintain workflows to provide purification support for cell line and cell culture development.
- Execute in-process testing methods using ELISA, HPLC, UV, and SDS-Page.
Qualifications / Skills
- Typically requires a PhD in Biology, Biochemistry, Chemical Engineering, or related field plus 10+ years’ related experience.
- Experience with purification process characterization and validation.
- Experience reviewing batch records; familiarity with Process Performance Qualification (PPQ) campaigns.
- Track record representing bioprocess functions in cross-functional teams and working with CMOs.
- Broad experience in process characterization, design of experiments, and analytics.
- Experience developing protein purification processes for early or late-stage clinical production.
- Expertise in AKTA systems and antibody characterization methods (HPLC, LC/MS, SDS-PAGE, DLS, and other biophysical techniques).
- Excellent critical thinking, scientific problem-solving, and communication skills.
- Familiarity with BLA authoring (preferred).
- Knowledge of process virology and viral clearance studies with contract labs (preferred).
Benefits / Compensation (if applicable)
- Salary range: $159,000.00–$207,000.00
- Competitive total rewards package including 401(k), healthcare coverage, and ESPP.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers
- Independently lead purification/downstream process characterization, tech transfer, and late-stage activities.
- Author protocols; coordinate study execution; review analytical results; generate/review reports; author IND/BLA sections.
- Coordinate internal team to generate late-stage process characterization/validation data packages.
- Support selection/coordination of CDMOs to generate high-quality late-stage data packages.
- Transfer purification processes to CMOs and support ongoing manufacturing as needed.
- Support other late-stage projects and apply lessons learned.
- Design and execute lab-scale chromatography and filtration studies to inform large-scale decisions.
- Maintain workflows to provide purification support for cell line and cell culture development.
- Execute in-process testing methods using ELISA, HPLC, UV, and SDS-Page.
Qualifications / Skills
- Typically requires a PhD in Biology, Biochemistry, Chemical Engineering, or related field plus 10+ years’ related experience.
- Experience with purification process characterization and validation.
- Experience reviewing batch records; familiarity with Process Performance Qualification (PPQ) campaigns.
- Track record representing bioprocess functions in cross-functional teams and working with CMOs.
- Broad experience in process characterization, design of experiments, and analytics.
- Experience developing protein purification processes for early or late-stage clinical production.
- Expertise in AKTA systems and antibody characterization methods (HPLC, LC/MS, SDS-PAGE, DLS, and other biophysical techniques).
- Excellent critical thinking, scientific problem-solving, and communication skills.
- Familiarity with BLA authoring (preferred).
- Knowledge of process virology and viral clearance studies with contract labs (preferred).
Benefits / Compensation (if applicable)
- Salary range: $159,000.00–$207,000.00
- Competitive total rewards package including 401(k), healthcare coverage, and ESPP.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers