Overview In this Senior Scientist role, you advance biomarker method development and validation within a CRO setting. You will work with cross-functional teams to support biomarker-focused studies and ensure timely, GLP/cGMP-compliant deliverables. You'll interact with clients to discuss study plans and results, and leverage state-of-the-art biomarker platforms to drive assay development. The position offers exposure to cutting-edge technologies and meaningful contributions to drug development programs.
Compensation / Benefits- health and dental insurance
- 401(k) plan
- disability insurance
- life insurance
Responsibilities- Conduct method development and validation for bioanalytical methods targeting biomarkers
- Generate updates and reports, troubleshoot issues, and uphold timelines
- Prepare and review study protocols, test reports, SOPs, deviations, and change controls
- Directly communicate with clients regarding study progress and outcomes
- Ensure GLP and/or cGMP compliance in daily tasks
- Operate instruments such as LC-MS, SIMOA, MSD, SP-X, ELLA
- Support biomarker assay development initiatives and integration of new technologies (e.g., ELLA, Luminex)
- Maintain accurate documentation and data integrity per regulatory standards
Key requirements- M.S. with 3+ years of experience or Ph.D. level
- Experience with bioanalytical method development and validation
- Proficiency with LC-MS, SIMOA, MSD, SP-X, ELLA or similar platforms
- Knowledge of GLP/cGMP regulatory requirements
- Strong client communication skills
- Ability to prepare and review protocols, reports, and change controls
- strong communication
- problem-solving
- timeline management
- bioanalytical method development
- validation of analytical methods for biomarkers
- instrumentation: LC-MS, SIMOA, MSD, SP-X, ELLA
