Principle Scientist

Full Time
Posted 4 months ago

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

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