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Associate Director, Bioanalytical & Biomarker Development
60% - Research/identify/design and implement high complexity bioanalytical test methods and/or biomarker strategies.
10% - Schedules technical work, analyzes data, and/or provides input in the interpretation of data.
10% - Manages external vendors/CROs
10% - Assesses progress relative to objectives and communicates progress periodically to supervisor and key stakeholders within and outside Group.
10%- Performs high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards.
Education and Experience Requirements:
• 10+ years of industry experience.
• Experience developing and validating (GLP/GMP) analytical and/or bioanalytical test methods required for large and small molecules.
• Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices is required, eg, FDA Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP).
• Experience in a regulated (GLP/GCP/GMP/CLIA) laboratory environment is a must.
• Experience placing and managing external work at CROs/CMOs is required.
Key Skills and Competencies:
• Expertise on exploratory biomarker studies including qualification, validation and sample testing in a GLP/CLIA environment for large and small molecules
• Expertise in development of methods to support ADME/biodistribution studies, eg, detecting analyte(s), metabolites and biomarkers in various matrices (eg, serum, CSF, urine) and tissues (eg, brain, spinal cord, liver, kidney, spleen, etc.)
• Expertise in lipid, targeted peptide/oligosaccharides/protein analysis using mass spectrometry
• Hands-on bench experience and problem solving skills in above fields are required
• Excellent management and organizational skills, and attention to detail, are essential.
• Excellent written and oral communication skills are required.
• Ability to identify root cause and develop solutions to a variety of complex problems.
• Broad knowledge of the theory of operation and application of advanced bioanalytical assay methods/platforms is required (ie, enzymatic, immunochemical, chromatographic, radiometric, mass spectrometric, ECL, PCR, SPR, etc.).
• Experience with development, validation and performance of bioanalytical assay methods in a regulated Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP) environment is required.
• Cross/inter-departmental representation experience, eg, on project teams, is highly preferred.
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