ISO17025 Dietary supplement, food, and cosmetic analytical testing laboratory. Bioanalytical contract research specializing in PK/PD, analytical method development, and in vitro ADME services. • Developed strategy and target markets for testing and contract research services• Manage, train, and support sales team - including client visits and calls• Manage marketing team• Manage team of scientists, overseeing analytical and bioassay method development • Direct writing of custom contract research proposals• Develop company budget, forecasts, and managed company finances

Advisory role for small molecule pre-clinical drug development startup.

Founded Niva Research, an analytical testing lab and contract research lab serving the biotech and pharmaceutical industries.• Oversaw location, planning, and development of laboratory facility buildout.• Recruited, hired, and managed team of 35 members.• Head of Contract Research • Head of Sales & Marketing

Led successful development of Enfortumab Vedotin (FDA approved), progressed 5 Antibody Drug Conjugates (ADCs) to Phase 1/2, and developed a robust pipeline of next generation ADCs.• Managed the conjugation group, ensuring the production of ADCs for all of research from in vitro scale (mg) to toxicology scale (multi-gram).• Managed Technology Transfer for clinical drug product.• Drove clinical manufacturing process development.• Represented chemistry department on multiple project teams.• Developed methods to conjugate novel drug linkers to antibodies.• Proposed and led the initiative to identify the metabolites and intracellular trafficking of novel ADC payloads.• Led research efforts to discover a conjugation format with superior stability and therapeutic index, which was adopted by the company as a platform technology.• Authored portions of several IND filings.• Presented data at conferences and published in peer-reviewed journals.• The first and only graduate of the Ph.D.-level Agensys Thesis Program (completed 3-year research project investigating the metabolism and intracellular trafficking of ADCs)

Lead role in developing methods to improve the yield and viability of human hepatocytes, includingcell isolation from non-transplantable livers.• Optimized cell culture techniques and investigated the impact of culture methods on the expression ofdrug metabolizing enzymes, especially Cytochrome P450 isoforms.• Performed hepatic drug metabolism and enzyme induction studies • HPLC and LC-MS/MS small molecule analysis• Developed cell cryopreservation media and protocols and authored protocols, reports, and SOPs.• Managed the hepatocyte cell line production group

Embrel process development research.