Lead Scientist

Description

• 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.
• Assist 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.

Qualifications

• 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. However, a combination of experience and/or education will be taken into consideration.
• Must 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.). Must be familiar with Good Laboratory Practices (GLP) regulations.
• Must possess good communication (oral and written) and analytical skills. Must 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.
• Position functions autonomously and includes the direct supervision of employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include training employees as well as planning, assigning, and directing work.
• 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.
• Typically sitting at a desk or table with intermittent sitting, standing, walking, or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Light lifting requirements.
• Normal laboratory situation. Regular exposure to chemicals, solvents, fumes, and/or gasses. Routine handling of human biological samples (e.g. whole blood, plasma, and serum).
• Proficiency in speaking, comprehending, reading and writing English is required.