Sr. Manager, Analytical Development
BridgeBio
September 01, 2026
Remote friendly (San Francisco, CA)
United States
Operations
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.
Responsibilities
- 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.
Qualifications
- 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, TrackWise, and LIMS.
Skills/Requirements
- 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.
Where You'll Work
- Hybrid role; in-office collaboration 2x per week in San Francisco.
Compensation/Benefits (if included)
- Salary range (California): $175,000–$185,000 USD.
- 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.
Responsibilities
- 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.
Qualifications
- 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, TrackWise, and LIMS.
Skills/Requirements
- 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.
Where You'll Work
- Hybrid role; in-office collaboration 2x per week in San Francisco.
Compensation/Benefits (if included)
- Salary range (California): $175,000–$185,000 USD.