Senior Manager Analytical Operations

BridgeBio
San Francisco, United States
Workplace: HybridFull timeUSD 130,000 - 159,700 annuallyFunction: Solutions Engineering & Sales EngineeringExperience: 10+ yearsSkills: ["Communication","Collaboration","Independent decision-making","Vendor management","Prioritization"]

Manage analytical development, quality control, and stability activities at contract drug substance and drug product manufacturing sites. Lead review and execution of method transfer, method validation, and stability protocols, and author or approve analytical technical and CMC sections for regulatory filings (US and ex-US). Partner closely with Quality Assurance to close investigations, deviations, and CAPAs, while overseeing reference standards, critical reagents programs, and batch release support.

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BridgeBio
BridgeBio
1 day ago

Senior Manager Analytical Operations

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Last checked: 29 minutes agoStatus: Live

Job Summary

Manage analytical development, quality control, and stability activities at contract drug substance and drug product manufacturing sites. Lead review and execution of method transfer, method validation, and stability protocols, and author or approve analytical technical and CMC sections for regulatory filings (US and ex-US). Partner closely with Quality Assurance to close investigations, deviations, and CAPAs, while overseeing reference standards, critical reagents programs, and batch release support.
Location: San Francisco, United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Solutions Engineering & Sales Engineering
Seniority: Sr. Manager level

Key Responsibilities

  • •Manage contract drug substance and drug product analytical development and quality control activities and timelines.
  • •Review analytical method transfer documentation and analytical method validation protocols/reports.
  • •Review stability protocols and monitor stability programs, including data trending and analysis.
  • •Author, review, and approve analytical technical reports and relevant CMC sections for US and ex-US regulatory filings.
  • •Partner with Quality Assurance to close investigations/deviations, manage change controls, and lead OOS/OOT investigations and CAPAs.
Travel: Low travel

Pay and Benefits

Salary: USD 130,000 - 159,700 annually
Perks:Health InsuranceDentalVision401kEquityHsaPaid LeaveParental LeaveLearning Budget

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 biologic and small molecule development.
  • •Thorough knowledge of cGMPs, USP, and ICH guidelines and stability program management (protocol design, data trending/analysis, shelf-life assignment/extension).
  • •Proficiency with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS.
Experience:10+ yearsPharmaceuticalsBiologicsSmall molecules
Skills:CommunicationCollaborationIndependent decision-makingVendor managementPrioritization
Tech Stack:JMPVeeva VaultTrackWiseLIMS

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