Lead Scientist

Key Responsibilities

• Develop and validate quantitative and/or immunogenicity assays in support of studies conducted in the Bioanalytical Laboratory that are compliant with applicable regulatory guidance.
• Design, perform, and evaluate method development and validation experiments supporting quantitative and/or immunogenicity assays to be used in the Bioanalytical Laboratory.
• Manage Scientists and other laboratory personnel in the performance of method development and validation experiments within the Bioanalytical Laboratory, as assigned.
• Evaluate, summarize and present analytical results and progress to Bioanalytical Laboratory management and clinical program teams as required for specific methods and drug product programs.
• Serve as a bioanalytical subject matter expert (SME) to clinical operations program teams.
• Document laboratory activity in accordance with established procedures.
• Write, review and approve Bioanalytical Laboratory reports.
• Aid in troubleshooting analytical problems encountered during study sample analysis within the Bioanalytical Laboratory.
• Serve as a scientific/technical information resource for junior laboratory staff.
• Review data and associated documentation for scientific soundness and compliance with Standard Operating Procedures and regulatory guidelines.
• Write, review, and approve analytical methods and standard operating procedures within the Bioanalytical Laboratory.
• Perform other duties as assigned.

Minimum Qualifications

• A minimum of a Bachelor's degree (or equivalent) and 7-10 years of experience.
• A Doctorate and 6 years experience, a Masters and 8 years experience, or a Bachelor's degree and 10 years experience preferred.
• Possess knowledge of the techniques and instrumentation employed in quantitative bioanalysis and/or immunogenicity testing (e.g. HPLC, mass spectrometry, ligand binding assays, laboratory automation, sample preparation, etc.).
• Familiar with Good Laboratory Practices (GLP) regulations.
• Possess good communication (oral and written) and analytical skills.
• Have a working knowledge of common computer software packages (e.g. Microsoft Word and Excel) as well as instrument-specific control and data acquisition software.
• Ability to read and interpret complex business and/or technical documents.
• Ability to write comprehensive reports and detailed business correspondence.
• Ability to work with groups of people such as other departments and communicate known concepts.
• Ability to present to multidisciplinary groups and departments.
• Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
• Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
• Light lifting requirements.
• Normal laboratory situation.
• Routine handling of human biological samples (e.g. whole blood, plasma, and serum).
• Proficiency in speaking, comprehending, reading and writing English is required.