Principal Scientist, Purification Process Development
Denali Therapeutics
10 days ago
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; anticipate issues and drive execution.
- Author protocols; coordinate study execution; review analytical results; generate/review reports; author IND/BLA sections.
- Coordinate internal teams to generate late-stage process characterization and/or 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; apply lessons learned to current projects.
- Design and execute lab-scale chromatography and filtration studies to inform large-scale decisions.
- Maintain existing 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:
- PhD in Biology, Biochemistry, Chemical Engineering or related field + 10+ years’ related experience.
- Experience with purification process characterization and validation.
- Experience reviewing batch records; familiarity with Process Performance Qualification (PPQ).
- Track record representing bioprocess functions in cross-functional teams; work effectively with CMOs.
- Broad experience in process characterization, experimental design, and analytics.
- Experience developing protein purification processes for early or late-stage clinical production.
- Expertise with AKTA systems and antibody characterization (HPLC, LC/MS, SDS-PAGE, DLS, and other biophysical techniques).
- Excellent critical thinking, scientific problem-solving, and communication.
- BLA authoring familiarity preferred.
- Process virology knowledge and viral clearance planning/execution with contract labs preferred.
Benefits:
- Competitive total rewards package including 401k, 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; anticipate issues and drive execution.
- Author protocols; coordinate study execution; review analytical results; generate/review reports; author IND/BLA sections.
- Coordinate internal teams to generate late-stage process characterization and/or 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; apply lessons learned to current projects.
- Design and execute lab-scale chromatography and filtration studies to inform large-scale decisions.
- Maintain existing 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:
- PhD in Biology, Biochemistry, Chemical Engineering or related field + 10+ years’ related experience.
- Experience with purification process characterization and validation.
- Experience reviewing batch records; familiarity with Process Performance Qualification (PPQ).
- Track record representing bioprocess functions in cross-functional teams; work effectively with CMOs.
- Broad experience in process characterization, experimental design, and analytics.
- Experience developing protein purification processes for early or late-stage clinical production.
- Expertise with AKTA systems and antibody characterization (HPLC, LC/MS, SDS-PAGE, DLS, and other biophysical techniques).
- Excellent critical thinking, scientific problem-solving, and communication.
- BLA authoring familiarity preferred.
- Process virology knowledge and viral clearance planning/execution with contract labs preferred.
Benefits:
- Competitive total rewards package including 401k, healthcare coverage, and ESPP.
Application instructions:
- Learn more at https://www.denalitherapeutics.com/careers