Senior Scientist, Large Molecule Analytical & Formulation Dev (Characterization)
Denali Therapeutics
5 hours ago
Remote friendly (South San Francisco, CA)
United States
Operations
Key Accountabilities / Core Job Responsibilities:
- Lead internal large molecule CMC-focused mass spectrometry and extended characterization activities, including primary sequence determination, PTM analysis, and higher order structure characterization.
- Develop phase-appropriate product extended characterization strategies, including early vs. late phase structure elucidation and characterization of product variants and forced degraded samples.
- Hands-on LC-MS based characterization to support comparability, CQA assessments, structure-function-activity relationships, and product understanding.
- Author and review technical development documents and relevant sections of health authority filings.
- Maintain timely and accurate lab records.
- Provide rapid analytical support for cell-line, bioprocess, and formulation development.
- Support late phase analytical development and product characterization for large molecule CMC programs.
- Contribute to overall analytical control strategy for commercialization of complex biotherapeutics.
- Oversee product characterization strategy/execution for structure, forced degraded panels, and minor variants.
- Perform critical quality attribute (CQA) assessments.
- Oversee analytical method transfer, qualification, and validation at internal/external QC labs.
Qualifications / Skills:
- PhD in Analytical Chemistry, Chemical Engineering, Biophysics, or related field + 3+ years CMC-focused analytical development in protein therapeutics (MS 8+ or BS 10+ years).
- In-depth, hands-on mass spectrometry method development and application (intact/reduced MS, subunit analysis, peptide mapping, N-/O-glycosylation profiling, disulfide linkage determination, LC-MS/MS).
- Experience with protein therapeutic variants and forced degradation samples.
- Experience authoring IND/BLA sections (e.g., analytical comparability, structure elucidation, justification of specifications).
- Experience with analytical protein characterization/biophysical methods (e.g., HPLC, cIEF, capillary electrophoresis, LC/MS MAM, peptide mapping, spectrophotometry, light scattering).
- Track record transferring/qualifying analytical methods, developing control strategies, and supporting health authority submissions.
- Strong DoE/statistical approaches for method development, robustness testing, and data analysis.
- Excellent communication, collaboration, organization, and problem-solving.
Compensation / Benefits:
- Salary range: $147,000.00–$191,000.00; competitive total rewards including 401k, healthcare coverage, ESPP, and other benefits.
Application instructions:
- Learn more at https://www.denalitherapeutics.com/careers.
- Lead internal large molecule CMC-focused mass spectrometry and extended characterization activities, including primary sequence determination, PTM analysis, and higher order structure characterization.
- Develop phase-appropriate product extended characterization strategies, including early vs. late phase structure elucidation and characterization of product variants and forced degraded samples.
- Hands-on LC-MS based characterization to support comparability, CQA assessments, structure-function-activity relationships, and product understanding.
- Author and review technical development documents and relevant sections of health authority filings.
- Maintain timely and accurate lab records.
- Provide rapid analytical support for cell-line, bioprocess, and formulation development.
- Support late phase analytical development and product characterization for large molecule CMC programs.
- Contribute to overall analytical control strategy for commercialization of complex biotherapeutics.
- Oversee product characterization strategy/execution for structure, forced degraded panels, and minor variants.
- Perform critical quality attribute (CQA) assessments.
- Oversee analytical method transfer, qualification, and validation at internal/external QC labs.
Qualifications / Skills:
- PhD in Analytical Chemistry, Chemical Engineering, Biophysics, or related field + 3+ years CMC-focused analytical development in protein therapeutics (MS 8+ or BS 10+ years).
- In-depth, hands-on mass spectrometry method development and application (intact/reduced MS, subunit analysis, peptide mapping, N-/O-glycosylation profiling, disulfide linkage determination, LC-MS/MS).
- Experience with protein therapeutic variants and forced degradation samples.
- Experience authoring IND/BLA sections (e.g., analytical comparability, structure elucidation, justification of specifications).
- Experience with analytical protein characterization/biophysical methods (e.g., HPLC, cIEF, capillary electrophoresis, LC/MS MAM, peptide mapping, spectrophotometry, light scattering).
- Track record transferring/qualifying analytical methods, developing control strategies, and supporting health authority submissions.
- Strong DoE/statistical approaches for method development, robustness testing, and data analysis.
- Excellent communication, collaboration, organization, and problem-solving.
Compensation / Benefits:
- Salary range: $147,000.00–$191,000.00; competitive total rewards including 401k, healthcare coverage, ESPP, and other benefits.
Application instructions:
- Learn more at https://www.denalitherapeutics.com/careers.