BEPC has an open position for a Research Associate III

Location: South San Francisco, CA
Requisition ID: ROCGJP00020576
Contract Length: 1 year contract with possibilities for extensions
Benefits: Medical, Dental, Vision and Life Insurance
Pay Rate: $50 – 57/hr.

Department: BioAnalytical Sciences Operations (BAS Ops)
Position: SE5/6-Scientist 2/3 – Technical Oversight of Outsourced Methods (LC-MS/MS)

Job Description:

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.

Qualifications:

· Bachelor’s or Master’s 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

Job Type: Contract

Pay: $50.00 - $57.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person

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