Scientist - Bioassay
San Francisco Metro Area, CA
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.
- 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:
- anti-drug antibodies (ADA and Cell based Nab assays)
- 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.
- 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