Consultant for 4 months

Covering 10 state Midwest geography selectively channeling Solid Oral Dose formulation, product development and manufacturing to 5 NAM sites and 2 UK sites. Schedule I – V drugs and potent compounds, pre-clinical to Phase 2.

GMP and CMC laboratory services to support pharmaceutical development; method development, validation, stability, formulation, batch release and extractables / leachables. Additionally, sold GMP aseptic sterile manufacturing, for liquid and lyophilization products. Batch sizes less than 50,000. Controlled Drug Schedule II – V. Covering 15 states in the Southeast USA.

Limited GMP and CMC laboratory services to support pharmaceutical development. This role was for the New Jersey site only, and focused on Elemental Impurities, including extractables / leachable. Method development for validation and stability, as it applied to early pre-clinical chemistry. The facility addressed Controlled Drug Schedule II – V. Covering 15 states in the Southeast USA.

Full service clinical CDMO for Phase I, II, and III clients, providing contract clinical supply materials. Services include - solid dose formulation, placebo manufacturing, tableting, capsuling, over-encapsulating, various packaging scenarios including blistering, labeling, kitting, storage, distribution, logistics and IRT. Controlled Drug Schedule II – V. Territory defined as central and southeast USA representing 27 states.

R&D and Quality Control contract analytical testing. Responsible for all pharmaceutical, biopharmaceutical and medical device accounts in 13 state southeastern US geography for a $6 Billion multinational corporation with 5 North American laboratories. Controlled Drug Schedule I – V. Customer profiles include API through Finished Product and include all aspects of drug development requirements from pre-clinical testing to commercialization.