A senior level, scientific and business-minded leader with a proven record in bioanalytical laboratory management. Extensive experience in the area of bioanalytical GLP operations and regulatory requirements with particular focus on PK and immunogenicity of biopharmaceutical products. • Extensive experience supporting bioanalytical assays in support of preclinical and clinical drug development programs for a variety of biopharmaceuticals (mAbs, fusion proteins, peptides, cytokines, clotting factors). • Oversee the design, development, and validation of a variety of biological immunoassays using multiple assay platforms. Experienced in immunogenicity, pharmacokinetic, neutralizing antibody and biomarker assays. • Demonstrated ability to troubleshoot difficult immunoassays (quantitative and immunogenicity) pertaining to pre-existing anti-drug antibodies, soluble target interference, matrix interference, reagent selection. • Experienced in 21CFR58 and 21CFR11 FDA regulatory compliance.• Responsible for optimizing workflow for bioanalytical laboratories with diverse operations resulting in sustained growth and profitability. • Involved in business development / marketing and continual expansion of the Immunoassay Laboratory service offerings.Specialties: • Quantitative (PK and Biomarker) and Immunogenicity (total and Nab) method development, transfer, validation and utilization in a GLP compliant manner. • Managing scientists and bioanalytical laboratory for pre-clinical and clinical development programs.• Continually improving methods of analysis and laboratory operation. • Demonstrated ability to simultaneously manage multiple, complex projects • Reagent preparation (antibody production and purification, reagent conjugation)
Listed skills include Glp, Drug Development, Clinical Development, Biopharmaceuticals, and 20 others.
