Joseph Herman Email and Phone Number

Experienced director of pharmaceutical and clinical laboratories with thorough knowledge working with CROs and CMOs. Most recently my primary focus has been on CMC for both drug substance and drug product manufacturing. I have directed the development, validation, and oversite of analytical methods in support of all phases of clinical trials, IND and NDA filings, CMC of API and drug product manufacture, bioanalysis, formulation development, and stability studies. Write and implement SOPs for regulatory compliance in pharmaceutical and clinical environments (FDA and CLIA). Identify new technology and instrumentation, evaluate feasibility and proof of concept to obtain medical device status on multiple projects. Expertise with clinical/toxicology applications including working knowledge of medicinal chemistry, combinatorial chemistry, ADME, (PK, PD, toxicology, metabolism), formulations and CMC. Author of five book chapters on LC/MS; pharmaceutical applications, clinical diagnostics, and environmental and food safety, along with seven patents on instrument design. Internationally recognized leader on turbulent flow chromatography and related uses for on-line sample preparation. Experienced in environmental testing in humans for exposure to heavy metals, pesticides, PFAS and VOCs. Familiar with and have worked under GLP, GMP, and GCP. I know FDA, CLIA, CAP and COLA regulations and I am experienced with the following ISO statutes; 9001, 13485, 14001, 17025 and 31000. I am a certified Lean Six Sigma Black Belt. Looking to utilize my expertise in bioanalytical methodologies and LC/MS to develop new laboratories, implement regulatory complacence, and develop staff.