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US: Associate Director, Bioanalytical

Date: 20-Aug-2013
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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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