Job Summary:

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.

Responsibilities: 

• 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.

Education/Abilities Requirements:

• 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