Sr. Manager, Analytical Development

What You'll Do

• Manage analytical development, QC, and stability activities at contract manufacturing sites and contribute to the development of clinical assets and regulatory submissions.
• Collaborate closely with Drug Substance, Drug Product, and Quality Assurance.

• Manage contract drug substance and drug product analytical development and QC activities and timelines.
• Author and review analytical method transfer and validation protocols and reports.
• Support batch release by reviewing/approving sampling plans and analytical data; generate/maintain CoAs, CoTs, and product specifications.
• Review stability protocols and monitor stability programs.
• Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.
• Partner with QA on change controls; lead OOS/OOT and deviation investigations, identify root causes, and implement CAPAs.
• Develop, revise, and approve SOPs and QC processes.

• At least 10 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting.
• Familiarity with CMC analytical regulatory requirements; authoring IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries.
• Independent proficiency in analytical techniques for biologics and small molecules.
• Thorough understanding of cGMPs, USP, and ICH guidelines.
• Stability program management expertise (protocol design, data trending/analysis such as JMP, shelf-life assignment/extension).
• Proficiency with Veeva Vault, Track Wise, and LIMS.

• Excellent verbal and written communication; ability to communicate with vendors and prioritize to meet timelines.
• Ability to adapt to changing priorities and make independent decisions under tight timelines.
• 5–15% travel; ability to travel internationally.

• Hybrid role; in-office collaboration 2x per week in San Francisco.

• Salary range (California): $175,000–$185,000 USD.