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Scientist II/III

South San Francisco, CA 94080

Posted: 03/04/2023 Employment Type: Contract Job Category: Scientific Job Number: 534360 Is job remote?: No Country: United States

Job Description


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:
  • 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 
Target Pay Rate: $50-$60/hr. Salary will be commensurate with experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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