Senior Scientist, Protein Assay Development

Senior Scientist, Protein Assay Development
Redwood City, CA

Position Summary

We are looking for a Senior Scientist to join our team in our Redwood City office. This position reports to the Senior Director, Assay Development.  This person will be working with Assay Development, Quality Control, Process Development, and Clinical teams. This role is responsible for developing, qualifying, transferring, documenting, and troubleshooting product characterization and bioanalytical assays using protein analytical technologies.

What You'll Do

  • Participate in the development, qualification, validation, and transfer of quantitative and semi-quantitative protein analytical methods to support product release as well as preclinical, and clinical sample bioanalysis
  • 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 regulatory 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
  • Maintain excellent laboratory notebook documentation
  • Supervise more junior scientists
  • Other responsibilities may be assigned as needed

About You

  • PhD degree and 8+ years of relevant biotechnology industry experience, Master's degree and 10+ years of relevant biotechnology industry experience, or Bachelor's degree and 14+ years of relevant biotechnology industry experience
  • Experience working as part of a project team
  • Experience supervising a group of scientists at various levels
  • Understanding of QC assay requirements
  • Understanding of requirements for pharmacokinetic assays
  • Extensive experience in assay development, troubleshooting, validation, qualification, and transfer.
  • Experience in developing large-molecule and biologics assays in a regulated environment to support some or all of the following: cell-based assays, LCMS, spectroscopy, enzyme kinetics assays, ELISA, MSD, or other ligand-binding assay technologies
  • Peer-reviewed publications in the area of assay development a plus
  • Working knowledge of basic statistics
  • Knowledge of MicroSoft Office Suite. Experience with SoftMax Pro a plus. Experience with GraphPad Prism a plus. Experience with JMP a plus.

Job Details

Job Type: Direct Placement
Location: Redwood City, CA
Job ID: 20-03844
Date Updated: June 30, 2020