Research Associate III
1 DNA Way South San Francisco, CA 94080
The Senior Scientific Researcher will support Genentech research and development projects by:
- Being the front line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (LC-MS/MS, LBA, new technologies) and any technical questions that arise around clinical, non-clinical study data.
- Technical oversight of outsourced methods (LC-MS/MS, LBA, new technologies) ensuring the qualified/validated state to ensure optimal assay quality
- Monitor assay performance through data analysis and interpretation.
- Communicate and present assay performance data and interpretation on an on-going basis to stake holders
- Oversee incorporation and expiration extension of reagents by reviewing and approving assay data and associated documents
- Designing and reviewing in-study validation experiments.
- Review CRO method validation reports and addendums
- Lead investigation of assay performance
- May generate anti-therapeutic antibody cutpoint factors using the ATA cutpoint tool using CRO data for immunogenicity methods.
- May coordinate cross validation experiments at CROs and generate cross validation reports.
- Review of clinical and non-clinical study data.
- Review CRO bioanalytical reports.
- Lead investigation of unexpected study data.
- May write or contribute to sections of Regulatory Documents (IND, BLA, variations, line extensions etc.)
- May serve as a functional area project representative
The individual will maintain appropriate regulatory compliance in supporting clinical and non-clinical assays and studies, and will apply thorough and accurate documentation skills. The Senior Scientific Researcher may train others on group responsibilities and systems. S/he may also be responsible for implementation or maintenance of support systems and may lead department teams charged with improving business processes.
Bachelor’ s degree or higher in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience 5-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO). Familiarity with bioanalytical method GxP compliance is required. The SSR will be required to have a proven technical background in developing, validating, implementing, maintaining, and troubleshooting/problem solving abilities of bioanalytical methods in one or more of the following areas: LC-MS (liquid chromatography and mass spectrometry), LBA (PK and ATA), and new technologies.