1 DNA Way South San Francisco, CA 94080 US
BioAnalytical Sciences Operations translates and applies strategy and innovation for bioanalysis and immunogenicity into clinical and non-clinical studies through global collaboration and robust CRO portfolio management. Our team brings technical and operational expertise along with passion and drive to make a difference for patients.
The Scientist 2/3 will support the development portfolio by providing technical oversight of clinical and non-clinical bioanalytical methods including validation and lifecycle management of LC MS/MS and Hybrid Immunoaffinity Capture LC-MS/MS supporting pharmacokinetic, toxicokinetic, pharmacodynamic, and biomarker analyses outsourced to Contract Research Organizations (CRO). The Scientist 2/3 will also review bioanalytical clinical and non-clinical method performance data generated at the CROs. The Scientist 2 or 3 will support the portfolio by:
- Serving as the front-line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (LC-MS/MS, Hybrid IA capture LC-MS/MS, new technologies) and any technical questions that arise around assay performance or lifecycle management during the course of clinical, non-clinical study assay performance.
- Providing technical oversight of outsourced methods (LC-MS/MS, Hybrid IA capture LC-MS/MS, new technologies), ensuring qualified/validated state for optimal assay quality:
- May transfer of critical reagents (Reference standards, MAbs, ligands) and any method documentation
- Technical review of assay data from development, feasibility, qualification/validation, assay performance from clinical/non-clinical sample analysis.
- Technical review of methods, plans (qualification/validation/sample analysis), reports (qualification/validation/sample analysis)
- Technical support during assay troubleshooting and lifecycle managment
- Proprietary Critical Reagents (Reference standards, MAbs, ligands): forecasting, requesting new material, shipping, re-test date extension.
- Supplemental validations to support additional matrices, disease states, co-medications, critical reagent incorporation,
- Coordinate assay transfers to multiple CROs and subsequent Technical support of cross validation experiments between CROs.
- Generate internal technical reports: validation history, cross validation, or memorandum * Share with internal key stakeholders assay data (transfer, feasibility, qualification, validation, troubleshooting, assay performance) and documents (methods, plans, reports, memorandum).
- May contribute to bioanalytical assays section of the Summary of Biopharmaceutics regulatory submission document.
- Lead technical teleconferences with CROs and attend internal bioanalytical working group meetings.
This individual will work in a fast-paced and highly collaborative team based environment. S/he will be asked to present at bioanalytical working groups or all staff meetings and to prepare poster presentations. S/he 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.
- Bachelors or Masters degree in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience 3-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO).
- Familiarity with bioanalytical method GxP compliance is required.
- The Scientist 2 or 3 may have a technical background in developing, validating, implementing, maintaining, and troubleshooting quantitative assays as well as have demonstrated problem solving abilities of bioanalytical methods in: LC-MS
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