Exploring the translational research and bioanalytical continuum.Providing strategic counsel and management for complex bioanalytical assays to quantify small molecule, oligo, peptides, protein drugs, antibodies, gene and cell therapies under GLP, GCP and CLIA. Additionally, providing guidance on integrated solutions for the measurement of clinical biomarkers within translational research to support drug discovery and development. Advising on the compilation and filing of bioanalytical contributions to INDs, NDAs, BLAs and other regulatory submissions and responses. Continuing to contribute to the external scientific and regulatory community through continued membership in the Steering Committee for the Bioanalytical Focus Group of the American Association of Pharmaceutical Scientists (AAPS), Clinical & Pharmaceutical Solutions through Analysis, publishing and regularly presenting and participating in scientific conferences and forums.

Covance has become Labcorp Drug DevelopmentThe Clinical Trials Testing Solution's (CTTS) Scientific Affairs Group's role is to use our experience and know how to help our clients hit their milestones. My responsibility is to collaborate with Bioanalytical, BioPharmCMC and Clinical Lab Solutions leadership to develop and drive a harmonized strategy that meets client current needs and prepares for future needs. I focus on expanding capabilities and capacity by collaborating across CTTS in leveraging technologies and best practices. My primary focus is around Bioanalytical capabilities supporting pharmacokinetic, immunogenicity, and pharmacodynamic (biomarker) measurements. Staff development is encouraged through training session, interactions and mentoring. As a subject matter expert, I participate in global scientific and regulatory issue discussions.

Site leader for full-service bioanalytical laboratory supporting the pharmaceutical industry. Capabilities include immunochemistry, cell-based andLC-MS assays for discovery, preclinical and clinical studies.

Led and managed two departments within the development portion R&D, delivering quantitative measures of new drug candidates and biomarkers to support nonclinical (GLP) and clinical (GCLP) translational research. Developed bioanalytical assays that supported early studies and were transitioned to contract laboratories to conduct later stage trials. Provided key regulatory filing documents and responses to health authority questions. Established and maintained alliances with contract research organizations; managed the quality and business aspects of the interface for bioanalytical and analytical (CMC) outsourcing. • Expanded Bioanalytical Sciences’ role in implementing complex bioanalytical LC-MS/MS assays to quantify small molecules, including oligonucleotides, millamolecules, protein drugs and biomarkers, providing essential data that advanced drug candidates.• Developed and maintained productive relationships with collaborating departments (drug safety, metabolism and pharmacokinetics, regulatory compliance, clinical, pharmacokinetics) and project working groups through which deliverables solved project problems.• Actively developed staff through training, coaching and mentoring in scientific, technical, regulatory areas. Hired and retained leading bioanalytical scientists and managers. • Oversaw and guided departmental compliance practices and standard operating procedures (SOPSs) ensuring alignment with emerging regulations (FDA, EMA, MHLW) and thinking.• Operated as bioanalytical due diligence and acquisition integration lead.• Accountable for an outsourcing budget & implemented strategies saving more than $2M year-on-year.• Received Jack Grebb Excellence in Leadership Award (BMS 2012).• Contributed to the external scientific and regulatory community through chairing workshops, publications, presentations and participation in scientific conferences and forums, that advanced the global harmonization of regulations.

Provided strategic leadership and managed all development facing immunoassay and LC-MS bioanalytical, including outsourced work to quantify small molecule, oligonucleotides, protein drugs and related compounds in a GLP-like or GLP environment. Grew immunoassays capabilities until they were split off as a separate department in 2010. • Guided bioanalytical scientific program support with leading-edge technologies for R&D’s development portfolio for multiple yearly NDA and sNDA filings.• Contributed to efficiency and process improvement initiatives for clinical pharmacokinetic data management through Kaizen events, shortening the timeline by 4 person-weeks per study.• Rotational leadership of four Chemistry, Manufacturing, and Controls analytical teams: Industrial Hygiene, Analytical Strategic Operations, Microbiology and an Analytical Project Team (2013); learning the GMP-side of pharmaceutical development.• Monitored global regulatory changes and implemented compliant internal practices that aligned internal and contracted work.• Contributed to the external scientific and regulatory community through active membership in five scientific organizations. Regularly published, presented and participated in scientific conferences and forums. Cofounder of the Global Bioanalysis Consortium, which influenced global health authorities.

Provided scientific and strategic leadership of Bioanalytical Sciences, including immunochemistry, immunogenicity, externalized science and late stage program development. Development team program representative for all ADME and bioanalytical support. • Tripled the immunochemistry group size, and implemented new technology and procedures to deliver enhanced pharmacokinetic and immunogenicity assay capabilities.• Identified and contributed to continuous improvement process changes that generated $500K in savings and shortened the IND timeline, and improved quality and compliance.• Expanded external membership in the Steering Committee for the Bioanalytical Focus Group of the American Association of Pharmaceutical Scientists (AAPS) and the Planning Committee for the Land O’Lakes Bioanalytical Conference.

Developed extraction procedures for drugs and metabolites in biological fluids and tissues for analysis by HPLC (UV and radiochemical) and GC (NPD). Supervised a group of three professional scientists in their daily routine. Designed, conducted, analyzed and reported on in vivo and in vitro (aerobic and anaerobic) metabolic studies. Performed pharmacokinetic analyses from animal drug exposure and metabolism studies.

Responsible for preparing and presenting laboratory instruction and directing laboratory activities to Pharmacy students. Presented lectures on human pharmacology as needed.

Departments of Genetic Toxicology, Teratology and Skin Carcinogenicity

Collected and analyzed water and coal samples from a variety of sources in the Indiana area. Coal assays included measurement of sulfur and calorimetric content. Water, from operating mines and as part of site reclamation procedures, was tested for dissolved minerals, buffers, solids and pH.