Responsible for the conduct of method development, method validation and the analysis of samples using immunoassay methods, including ELISA, MSD, Cell based assays and others, in support of regulated pre-clinical and clinical bioanalytical studies for drug development programs.
- Able to lead and direct scientific work to support external methods and projects.
- Maintain up to date knowledge of scientific advances, analytical techniques, instrumentation, methodology, regulatory compliance, and industry guidelines relevant to bioanalysis.
- Develops and reviews protocols and sample analysis plans.
- Reviews method development data to ensure methods are ready for validation.
- Approves validation methods and reviews sample analysis methods.
- Independently reviews and approves raw data.
- Reviews and approves reports for scientific accuracy and completeness.
- Serves as a point of contact for the client.
- Works with the client to determine project requirements.
- Provides a technical resource for less experienced team members.
- Ensures that any circumstances that may affect the quality and integrity of the study are identified and documented as they occur, and appropriate corrective action taken.
- Provides appropriate coaching and recognition to team members.
- Able to plan, prioritize, and manage workload for large and complex projects.
- Ph.D. in Immunology/Immunochemistry or related discipline, M.S. degree in Immunochemistry or related discipline with 3+ years of experience or B.S. degree with 6+ years of directly related experience and/or equivalent work experience in an appropriate scientific discipline
- Excellent communication and interpersonal skills
- Excellent attention to detail
- Able to utilize word processing, database, spreadsheet, and specialized software
- Experience and skill with Watson, Nautilus, and Analyst preferred
- Knowledge of regulatory agency guidelines