Senior Manager Analytical Operations
BridgeBio
August 20, 2026
Remote friendly (United States)
United States
Operations
What You’ll Do
- Manage analytical development, QC, and stability activities at contract manufacturing sites and contribute to development of clinical assets and regulatory submissions.
- Collaborate with Drug Substance, Drug Product, and Quality Assurance groups.
- Apply knowledge of analytical techniques across modalities, including test method development, analytical method transfer, phase-appropriate method validation, and stability program management (data trending and analysis) for drug substances and drug products.
- Ensure compliance with relevant ICH quality guidelines.
Responsibilities
- Manage contract drug substance/drug product analytical development and QC timelines.
- Review analytical method transfer documentation.
- Review analytical method validation protocols/reports.
- Review stability protocols and monitor stability programs.
- Author/review/approve analytical technical reports.
- Author/review/adjudicate CMC sections for US and ex-US regulatory filings.
- Collaborate with QA to close investigations and deviations.
- Manage reference standards and critical reagents programs (qualification, re-testing strategies, bridging across CDMOs).
- Support batch release (review/approve sampling plans and analytical data); generate/maintain CoAs, CoTs, and product specifications.
- Lead OOS/OOT and deviation investigations; implement CAPAs; manage change controls.
- Develop/revise/approve SOPs and QC processes.
Who You Are
- At least 10 years of experience in Analytical Development and/or Quality Control in pharma.
Required skills/knowledge
- IND/IMPD/BLA/NDA/MAA filing experience and regulatory inquiry responses.
- Proficiency in analytical techniques supporting biologics and small molecules.
- Strong communication with vendors; prioritize to meet timelines.
- cGMP, USP, and ICH guideline knowledge; stability program expertise (protocol design, data trending/analysis such as JMP, shelf-life assignment/extension).
- Experience with Veeva Vault, TrackWise, and LIMS.
- Ability to work independently under tight timelines; adapt to priority changes.
- 5–15% travel, including international travel.
Benefits (explicitly listed)
- Market-leading compensation; 401(k) match; ESPP; referral bonus; pre-tax commuter benefits; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision; HSA + FSA; fertility/family-forming benefits; expanded mental health support; hybrid flexibility; flexible PTO; paid medical and parental leave.
Salary range (California)
- $130,000–$159,700 USD.
- Manage analytical development, QC, and stability activities at contract manufacturing sites and contribute to development of clinical assets and regulatory submissions.
- Collaborate with Drug Substance, Drug Product, and Quality Assurance groups.
- Apply knowledge of analytical techniques across modalities, including test method development, analytical method transfer, phase-appropriate method validation, and stability program management (data trending and analysis) for drug substances and drug products.
- Ensure compliance with relevant ICH quality guidelines.
Responsibilities
- Manage contract drug substance/drug product analytical development and QC timelines.
- Review analytical method transfer documentation.
- Review analytical method validation protocols/reports.
- Review stability protocols and monitor stability programs.
- Author/review/approve analytical technical reports.
- Author/review/adjudicate CMC sections for US and ex-US regulatory filings.
- Collaborate with QA to close investigations and deviations.
- Manage reference standards and critical reagents programs (qualification, re-testing strategies, bridging across CDMOs).
- Support batch release (review/approve sampling plans and analytical data); generate/maintain CoAs, CoTs, and product specifications.
- Lead OOS/OOT and deviation investigations; implement CAPAs; manage change controls.
- Develop/revise/approve SOPs and QC processes.
Who You Are
- At least 10 years of experience in Analytical Development and/or Quality Control in pharma.
Required skills/knowledge
- IND/IMPD/BLA/NDA/MAA filing experience and regulatory inquiry responses.
- Proficiency in analytical techniques supporting biologics and small molecules.
- Strong communication with vendors; prioritize to meet timelines.
- cGMP, USP, and ICH guideline knowledge; stability program expertise (protocol design, data trending/analysis such as JMP, shelf-life assignment/extension).
- Experience with Veeva Vault, TrackWise, and LIMS.
- Ability to work independently under tight timelines; adapt to priority changes.
- 5–15% travel, including international travel.
Benefits (explicitly listed)
- Market-leading compensation; 401(k) match; ESPP; referral bonus; pre-tax commuter benefits; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision; HSA + FSA; fertility/family-forming benefits; expanded mental health support; hybrid flexibility; flexible PTO; paid medical and parental leave.
Salary range (California)
- $130,000–$159,700 USD.