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Scientific. Clinical. Software Engineering

Scientist - Bioassay

San Francisco Metro Area, CA

Job Type: Scientific Job Number: JN -092020-27338 Region: San Francisco Metro Area

Job Description

Overview:

The ideal candidate will bring his/her experience with assay design, development, and implementation and become part of a team supporting the development of therapeutic antibodies. The individual will support the group with both the management and hands-on efforts necessary to develop bioanalytical assays for both pre-clinical and clinical programs. The individual must be collaborative, team-oriented and enjoy the fast-paced, multi-tasked, and hands-on research environment of a science and patient-centric company. This role will have the opportunity for significant career development/progression opportunities as our business continues to grow and expand.

Responsibilities:

  • Lead, develop, and mentor a high performing bioanalytical team
  • Hands on experience in designing, developing and troubleshooting methods suitable for use in GxP and clinical studies for:
    • Pharmacokinetic
    • Pharmacodynamic
    • anti-drug antibodies (ADA and Cell based Nab assays)
    • biomarkers
    • potency assay
  • Experienced in discovering and developing biomarker assays
  • Initiate and Manage relationships with Contract Research Organizations (CROs) for method transfer, validation, sample analysis and report generation
  • Experience in and knowledge of industry guidance for the development and validation of pK, immunogenicity immunoassays and bioassays, biomarkers and/or potency assays
  • Prepare reports, regulatory documents (e.g. INDs and BLAs)
  • Partner cross functionally with multidisciplinary areas within research, clinical, regulatory and QA/QC across multiple programs.

Qualifications:

  • Minimum PhD with 2+ years applicable experience or BS/MS with >10 years applicable experience
  • Proven track record of scientific, managerial, and collaboration work
  • Extensive hands-on experience with the design, development, optimization, qualification and validation of novel immunoassays and bioassays across multiple platforms and technologies (eg, ELISA, MSD, AlphaScreen, flow cytometry; cell based, etc.)
  • Demonstrated ability to identify, negotiate, and oversee outsourced services with vendors
  • Experience with financial budget planning and tracking.
  • High competence in common software and data analysis packages (eg, SoftMax Pro, GraphPad Prism, Microsoft Office, PowerPoint, Excel, Word). Knowledge of JMP a plus
  • Proven experience working in a bioanalytical laboratory environment is essential
  • Maintain current knowledge of the field and area(s) of scientific expertise and development
  • Data review, approval, analysis, graphing, reporting and presentation to internal and external audiences


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