Senior Scientist, Assay Development

Menlo Park, CA 94025

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

Job Description


Senior Scientist, Assay Development

Menlo Park CA

 

Senior Scientist, Assay Development

Our company is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases.

Their  Assay Development team is looking to bring onboard a Senior Scientist. This individual will support the Assay Development team by developing, qualifying, transferring, and troubleshooting quantitative, semi-quantitative, and qualitative assays in support of research, nonclinical, clinical, and CMC programs.

 

Core Duties and Responsibilities:
  • Plan strategies for and participate in the development, qualification, and transfer of quantitative and semi-quantitative bioanalytical methods to support product release
  • May also contribute to development, qualification, and transfer of bioanalytical methods to support preclinical and clinical assays
  • Present results, conclusions, and implications to project teams and senior management.
  • Participate in the transfer of processes, technology, and assays to/from internal and external collaborators and outside vendors
  • Maintain a detailed awareness of industry guidance and standards for assay validation and performance
  • Maintain current knowledge of advancing technologies and propose their applications to ongoing projects.
  • Author standard test methods and best-practices documents for the Assay Development group
  • Contribute to development reports
  • Contribute to CMC protocols and regulatory reports
  • Independently plan, implement, and complete significant projects with minimal supervision.
  • Participate in scientific meetings and produce original peer-reviewed publications

 

Position Requirements and Experience:
  • PhD degree and 5+ years relevant biotechnology industry experience preferred, or a Master’ s degree and 8+ years relevant biotechnology industry experience 
  • Experience working as part of a project team
  • Understanding of QC assay requirements
  • Understanding of assay validation
  • Experience in developing large-molecule and biologics assays in a regulated environment to support some or all of the following: potency assays, titer assays, cell-based assays, transduction assays, infectivity assays, qPCR assays, digital drop PCR, ELISA, MSD, or other ligand-binding assay technologies
  • Peer-reviewed publications in the area of assay development a plus
  • Working knowledge of basic statistics
  • Supervisory experience
  • Experience with NGS a plus
  • Knowledge of MicroSoft Office Suite. Experience with SoftMax Pro a plus. Experience with GraphPad Prism a plus. Experience with JMP a plus.

 

Meet Your Recruiter

Ron Tess

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