Senior Scientist, Assay Development

Menlo Park, CA 94025

Posted: 08/22/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16303

Senior Scientist, Assay D? evelopment

Menlo Park, CA<%? 2Fb>

 

Our? Assay Development team is looking to bring onboard a Senior? Scientist. This individual will support the Assay Development? team by developing, qualifying, transferring, and troubleshoot? ing quantitative, semi-quantitative, and qualitative assays in? support of research, nonclinical, clinical, and CMC progr? ams.

Core Duties and Responsibilities? :
  • Plan strategies? for and participate in the development, qualification, and t? ransfer of quantitative and semi-quantitative bioanalytical method? s to support product release
  • May also con? tribute to development, qualification, and transfer of bioanal? ytical methods to support preclinical and clinical assaysPresent results, conclusions, and implications? to project teams and senior management.
  • P? articipate in the transfer of processes, technology, and ass? ays to/from internal and external collaborators and outside ve? ndors
  • Maintain a detailed awareness of indu? stry guidance and standards for assay validation and performance?
  • Maintain current knowledge of advancing te? chnologies and propose their applications to ongoing projects.%3? C/li>
  • Author standard test methods and best-prac? tices documents for the Assay Development group
  • %? 3Cli> Contribute to development reports
  • Contri? bute to CMC protocols and regulatory reports
  • Independently plan, implement, and complete significant proj? ects with minimal supervision.
  • Participate? in scientific meetings and produce original peer-reviewed public? ations

Position Requireme? nts and Experience:
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  • Experience working as part of a project teamUnderstanding of QC assay requirements
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  • Understanding of assay validation
  • E? xperience in developing large-molecule and biologics assays in%2? 0a regulated environment to support some or all of the follo? wing: potency assays, titer assays, cell-based assays, t? ransduction assays, infectivity assays, qPCR assays, digital%2? 0drop PCR, ELISA, MSD, or other ligand-binding assay tec? hnologies
  • Peer-reviewed publications in the%2? 0area of assay development a plus
  • Working%2? 0knowledge of basic statistics
  • Supervisory experience
  • Experie? nce with NGS a plus
  • Knowledge of MicroSof? t Office Suite. Experience with SoftMax Pro a plus. Experi? ence with GraphPad Prism a plus. Experience with JMP a plu? s.

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