Sr. Manager, Analytical Development

BridgeBio
San Francisco
Workplace: HybridFull timeUSD 175,000 - 185,000 annuallyFunction: Product ManagementExperience: 10+ yearsSkills: ["Communication (verbal and written)","Independent decision-making","Cross-functional collaboration","Time management","Vendor communication"]

Lead analytical development, quality control, and stability activities across contract drug substance and drug product sites, partnering closely with Drug Substance, Drug Product, and Quality Assurance teams. Own test method development, method transfer, phase-appropriate validation, stability protocol review, and data trending/analysis. Support batch release, author CMC sections for US and ex-US filings, and drive change controls, OOS/OOT investigations, and CAPAs while ensuring cGMP/ICH compliance.

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FursaFursa
BridgeBio
BridgeBio
4 days ago

Sr. Manager, Analytical Development

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Last checked: 20 minutes agoStatus: Live

Job Summary

Lead analytical development, quality control, and stability activities across contract drug substance and drug product sites, partnering closely with Drug Substance, Drug Product, and Quality Assurance teams. Own test method development, method transfer, phase-appropriate validation, stability protocol review, and data trending/analysis. Support batch release, author CMC sections for US and ex-US filings, and drive change controls, OOS/OOT investigations, and CAPAs while ensuring cGMP/ICH compliance.
Location: San Francisco
Workplace: Hybrid
Employment Type: Full time
Job Function: Product Management
Seniority: Sr. Manager level

Key Responsibilities

  • •Manage contract drug substance and drug product analytical development and quality control activities, timelines, and deliverables.
  • •Author and review analytical method transfer and validation protocols and reports.
  • •Support direct batch release by reviewing/approving sampling plans and analytical data and maintaining CoAs, CoTs, and product specifications.
  • •Review stability protocols and monitor stability programs, including data trending and analysis.
  • •Author/review/adjudicate CMC sections for US and ex-US regulatory filings and partner with QA on change controls, OOS/OOT investigations, and CAPAs.
Travel: Low travel

Pay and Benefits

Salary: USD 175,000 - 185,000 annually
Perks:401kEsppHealth InsuranceDentalVisionHsaFsaAnnual BonusPaid LeavePaid HolidaysParental Leave

Key Requirements

  • •At least 10 years of experience in analytical development and/or quality control in a pharmaceutical setting.
  • •Experience with CMC analytical regulatory requirements and authoring IND/IMPD/BLA/NDA/MAA filings and regulatory responses.
  • •Independently proficient in analytical techniques supporting biologics and small molecules.
  • •Thorough understanding of cGMPs and USP/ICH guidelines and industry best practices.
  • •Subject matter expertise in stability program management, including protocol design, data trending/analysis (e.g., JMP), and shelf-life assignment/extension.
Experience:10+ yearsPharmaceuticalsBiotechAnalytical developmentQuality controlCMC regulatoryBiologicsSmall molecules
Skills:Communication (verbal and written)Independent decision-makingCross-functional collaborationTime managementVendor communication
Languages:English
Tech Stack:JMPVeeva VaultTrackWiseLIMSUSPICHINDIMPDBLANDAMAA

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn