Research Associate III
South San Francisco, CA | Job #: 19-00941
This is an excellent opportunity to start a career with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients' lives!
Title: Research Associate III
Location: South San Francisco, CA
Starting Contract: 3 year contract – opportunities for advancement!
Schedule: Full-time, M-F
This position will support the BioAnalytical Sciences (BAS) organization by providing technical oversight of clinical and non-clinical bioanalytical methods (LC-MS/MS, ligand binding assays (LBA), new technologies (Singulex, Quanterix, Gyros)) supporting pharmacokinetic, toxicokinetic, pharmacodynamic, immunogenicity, and biomarker analyses outsourced to Contract Research Organizations (CRO). The SSR will also review bioanalytical clinical and non-clinical study data generated at the CRO.
- 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
- 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.
- Specific to LC-MS, it is desirable for the SSR to have experience with quantitative small molecule and/or protein analysis with mass spectrometric assays.
- Excellent communication, interpersonal and organizational skills are essential.