Scientist, Biologics CMC Analytical Development
Gilead Sciences
18 days ago
Remote friendly (San Francisco Bay Area)
United States
Operations
Scientist, Biologics CMC Analytical Development
Responsibilities:
- Lead CMC analytical team for pre-pivotal biologics; define potential critical quality attributes (pCQAs) and phase-appropriate control strategies; support characterization for Toxicology and early clinical development (Phase I/II).
- Design, develop, and deploy robust analytical methods for product characterization and release/stability testing using advanced technologies (HPLC-UV/FLR/CAD/ELSD, CE/iCIEF, Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS); author method development reports, test procedures, and technical documentation.
- Evaluate and implement state-of-the-art analytical technologies and approaches to improve efficiency and molecular understanding.
- Provide technical oversight of internal/external analytical activities to ensure data integrity, regulatory compliance, and strong data governance across CRO/CDMO partnerships.
- Partner cross-functionally with Research, Process Development, Clinical Development, Safety, and Program Strategy across the product lifecycle.
- Present findings to senior leadership; author technical reports/manuscripts; support regulatory submissions (IND/IMPD/CTA) and intellectual property filings.
Qualifications:
- Ph.D. with 3+ years OR M.S. with 6+ years in Analytical Chemistry or related field focused on biologics (therapeutic proteins) CMC analytical development.
- Proven experience leading early-stage pre-pivotal CMC analytical programs (Toxicology, Phase I/II) and regulatory submissions (IND/IMPD).
- Strong experience in analytical method development, qualification/validation, and control strategy for biologics (HPLC, iCIEF, CE, LC-MS-based characterization/data analysis).
- Working knowledge of FDA/ICH expectations for drug substance and drug product quality.
- Ability to collaborate across CMC and cross-functional teams; familiarity with digital/data capabilities (lab automation, data governance, CSV, knowledge management).
- Commitment to fostering inclusive, high-performing teams.
Benefits/Compensation:
- Salary range: $146,540.00–$189,640.00. May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
Responsibilities:
- Lead CMC analytical team for pre-pivotal biologics; define potential critical quality attributes (pCQAs) and phase-appropriate control strategies; support characterization for Toxicology and early clinical development (Phase I/II).
- Design, develop, and deploy robust analytical methods for product characterization and release/stability testing using advanced technologies (HPLC-UV/FLR/CAD/ELSD, CE/iCIEF, Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS); author method development reports, test procedures, and technical documentation.
- Evaluate and implement state-of-the-art analytical technologies and approaches to improve efficiency and molecular understanding.
- Provide technical oversight of internal/external analytical activities to ensure data integrity, regulatory compliance, and strong data governance across CRO/CDMO partnerships.
- Partner cross-functionally with Research, Process Development, Clinical Development, Safety, and Program Strategy across the product lifecycle.
- Present findings to senior leadership; author technical reports/manuscripts; support regulatory submissions (IND/IMPD/CTA) and intellectual property filings.
Qualifications:
- Ph.D. with 3+ years OR M.S. with 6+ years in Analytical Chemistry or related field focused on biologics (therapeutic proteins) CMC analytical development.
- Proven experience leading early-stage pre-pivotal CMC analytical programs (Toxicology, Phase I/II) and regulatory submissions (IND/IMPD).
- Strong experience in analytical method development, qualification/validation, and control strategy for biologics (HPLC, iCIEF, CE, LC-MS-based characterization/data analysis).
- Working knowledge of FDA/ICH expectations for drug substance and drug product quality.
- Ability to collaborate across CMC and cross-functional teams; familiarity with digital/data capabilities (lab automation, data governance, CSV, knowledge management).
- Commitment to fostering inclusive, high-performing teams.
Benefits/Compensation:
- Salary range: $146,540.00–$189,640.00. May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.