Manager, Analytical Development

BridgeBio
United States
Workplace: RemoteFull timeUSD 144,000 - 159,000 annuallyFunction: Product ManagementExperience: 5+ yearsEducation: mastersSkills: ["Communication","Coordination","Data analysis"]

Manage development and tracking of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation, and site transfer under tight timelines. Coordinate with Analytical, CMC, QA, Regulatory, Project Management, and external CRO/CMO partners to support SOP, method, and specification reviews. Lead analytical review and stability tracking, assist with data generation/analysis, support OOS/OOT investigations, and contribute to regulatory filings for infigratinib programs.

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BridgeBio
BridgeBio
2 weeks ago

Manager, Analytical Development

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Source: Company careers pageValidated by: Fursa AI
Last checked: 21 hours agoStatus: Live

Job Summary

Manage development and tracking of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation, and site transfer under tight timelines. Coordinate with Analytical, CMC, QA, Regulatory, Project Management, and external CRO/CMO partners to support SOP, method, and specification reviews. Lead analytical review and stability tracking, assist with data generation/analysis, support OOS/OOT investigations, and contribute to regulatory filings for infigratinib programs.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Product Management
Seniority: Manager level

Key Responsibilities

  • •Manage development and tracking of stage-appropriate testing methodology for drug substance and drug product, including validation, transfers, and stability work.
  • •Coordinate analytical development activities with internal teams and external CROs/CMOs to advance programs to regulatory decision points.
  • •Lead critical review of SOPs, test methods, specifications, validation protocols/reports, method transfers, COAs, and stability documentation.
  • •Support contractor site investigations related to OOS/OOT and deviations.
  • •Support analytical (CMC) activities for the formulation of infigratinib and assist with regulatory filings, data review, and stability tracking.
Travel: High travel

Pay and Benefits

Salary: USD 144,000 - 159,000 annually
Perks:401kEsppHealth InsuranceDentalVisionHsaFsaPaid Leave

Key Requirements

  • •MS in Organic Chemistry, Analytical Chemistry, or Pharmaceutical Science.
  • •5+ years of experience in contract research or the pharmaceutical/biotech industry.
  • •Experience developing and applying analytical assays, impurity methods, and in-vitro (dissolution) release methods.
  • •Hands-on knowledge of HPLC and physicochemical properties, including methods development for drug substance and drug product.
  • •Knowledge of cGMP regulations and familiarity with compendial standards and FDA/EMA/ICH guidance documents.
Experience:5+ yearsBiotechPharmaceuticalsContract research
Education:Master's
Skills:CommunicationCoordinationData analysis
Languages:English
Tech Stack:HPLCCGMPUSPEPJPFDAEMAICHSOPsStability summariesCOAsInfigratinib

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