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BrainChild Bio

Posted 24 days ago

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Scientist, Analytical Development

SeattleOn-siteFull-time

AI Summary

Analytical Development Scientist leads a team performing routine analytical testing and method transfers for cell and gene therapy manufacturing, focusing on flow cytometry, qPCR/ddPCR, and multiplex cytokine detection in support of process development.

About this role

BrainChild Bio is seeking to hire an experienced Scientist in Analytical Development to add to our growing team supporting clinical development of CAR T therapies to treat pediatric brain malignancies. The Scientist will lead a team in support of routine analytical testing to enable process development and process characterization of cellular drug product manufacturing processes. The ideal candidate would have experience performing one or more types of analytical methods including cell-based assays, flow cytometry, cell counting platforms, qPCR, ddPCR and/or multiplex cytokine detection. The Scientist would also be familiar with ICH guidance and phase-appropriate method life cycle management, including method bridging strategies, in support of cell and gene therapy manufacturing. The candidate would also be a proficient problem solver and be able to work and communicate effectively in matrixed environments including internally across Analytical Development and Process Development teams.

Responsibilities:

  • Work collaboratively with BrainChild Bio Analytical Development and Process Development teams to coordinate method transfers, method optimizing/bridging, sample testing and data delivery.
  • Oversee experiment performance by team members, perform experiments, analyze and review data from flow cytometry, cell counting platforms, qPCR, ddPCR and/or multiplex cytokine detection methods and deliver results to process development teams.
  • Perform method optimization and method bridging studies to support high throughput process analytics.
  • Co-lead new analytical method transfers from Analytical Development and support existing method life cycle management.
  • Author ELNs, SOPs, protocols and reports.
  • Train and manage direct reports.

    • Qualifications:

  • Degree in biology, bioengineering, immunology, virology, microbiology or related discipline.
  • Scientist qualifications include PhD with 0-2 years, MA/MS with 4-6 years, or BA/BS with 6-8 years of experience.
  • Experience managing and collaborating with contract manufacturing organizations.
  • Experience with a broad range of cytometry platforms (BD, Beckman, Cytek, Sony, etc.) is highly desired.
  • Hands-on experience designing, developing, qualifying and transferring flow cytometry and spectral assays for QC release and/or characterization.
  • A team player with a track record of successfully operating within cross-functional teams.
  • Previous experience with analytical method qualification, transfer and life cycle management desired.
  • Proficiency with life science data analysis tools (FlowJo, Prism, JMP, Excel, etc.).

    • Skills

    BDBeckmanCell-based AssaysCell Counting PlatformsCytekData AnalysisDdPCRELNsExcelFlow CytometryFlowJoICH GuidanceJMPLife Cycle ManagementMethod QualificationMethod TransferMultiplex Cytokine DetectionPrismProtocolsQPCRSony ΑシリーズSOPsSpectral Flow Cytometry

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