Scientist (Protein Biophysical Characterization)
Redwood City, CA
We are looking for a Scientist/Senior Scientist to join our team in our Redwood City office. This position reports to Director-level personnel in Assay Development. This person will be working with Assay Development, Quality Control, Process Development, Preclinical, and Clinical teams. This role is responsible for developing, qualifying, transferring, documenting, and troubleshooting product characterization and bioanalytical assays using biophysical technologies.
- Participate in the development, qualification, validation, and transfer of quantitative and semi-quantitative biophysical characterization assays to support product release as well as preclinical, and clinical sample bioanalysis
- Evaluate, implement, and maintain new technology within Assay Development to support product release and 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.
- Serve as SME for biophysical assay technologies
- Participate in scientific meetings and produce original peer-reviewed publications
- Maintain excellent laboratory notebook documentation
- Mentor junior scientists
- Other responsibilities may be assigned as needed
- Sr. Scientist level - PhD degree and 8+ years of relevant biotechnology industry experience, Master's degree and 15+ years of relevant biotechnology industry experience, or Bachelor's degree and 20+ years of relevant biotechnology industry experience
- Scientist level - PhD degree and 2+ years of relevant biotechnology industry experience, Master's degree and 10+ years of relevant biotechnology industry experience, or Bachelor's degree and 15+ years of relevant biotechnology industry experience
- Experience working as part of a project team
- Experience mentoring a group of lab personnel at various levels
- Understanding of QC assay requirements
- Understanding of requirements for pharmacokinetic assays
- Extensive experience in assay development, troubleshooting, validation, qualification, and transfer
- Working knowledge in developing large-molecule and biologics assays in a regulated environment to support some or all of the following: light scattering, AUC, DSF, SPR, LCMS, or other biophysical assay technologies.
- Experience in enzyme assays and LBA techniques is a plus.
- Broad knowledge of gene therapy discovery and regulatory guidelines is desired
- Background in the area of AAV characterization a plus
- 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 Type: Direct Placement
Location: Redwood City, CA
Job ID: 21-00962
Date Updated: February 18, 2021