Thomas M. Email & Phone Number

Rochester, Ny, Us

Rochester, New York Area

Manage a Process Development Department of 16 people consisting of engineers, scientists and technicians.Responsible for managing a 2.5MM department budget that encompasses an aseptic processing pilot facility. Maintaining cGMP compliant aseptic processing facility.Lead the research efforts for new and streamlined developed processes for existing marketed sterile products and newly formulated sterile products.Lead the efforts to ensure successful product technology transfers meet pre-established process capabilities, and evaluating statistical analysis data generated using Minitab.Strong emphasis on developing skill sets for individuals in the Process Development Department.

Development of scale-up aseptic processes for sterile lens care solutions and sterile drug eye care solutions under GMP procedures. In addition, designed scale-up processes for semi-solid and oral care formulations.Transfer process technologies for ophthalmic solutions, semi-solid lotions, solid dosage forms and liquid formulations to domestic and international Bausch & Lomb and contract manufacturing facilities.Project Management experiences include assembly of a project team to reformulate an existing ophthalmic eyewash solution, modify its package and component configurations and transfer its production to a new manufacturing facility.

Development of ophthalmic lens care products for use with soft, hard and Rigid Gas Permeable contact lenses.Development of drug eye-care product formulations.

Development of new cosmetic skin care and OTC oral care products and reformulation of marketed cosmetic products.Development of Curel Nutrient Rich Lotion, a unique hand & body moisturizing lotion that was granted patent status on September 1998. Reformulation of marketed Curel Alpha-Hydroxy Acid Lotion for shelf life optimization.Reformulation of marketed skin care products to provide cost savings while maintaining product quality.Development of fluoride oral rinses.Preparation of chemistry documentation for a supplement to an existing NDA.

Development and formulation for new drug products and reformulation for existing marketed drug products under cGMP/GLP procedures.Development of a topical emulsion combination drug product that was novel to the U.S. pharmaceutical market. Phase 1 clinical supplies of this drug product were prepared and submitted successfully for IND clinical studies. Development of semi-solids (emulsions, creams and ointments), solids (tablets), liquids and suspensions for OTC market, consumer sensory studies or clinical studies.Experience in compilation of FDA drug approval applications (IND & NDA).Design and implementation of product stability programs.Reformulation of marketed products to improve product quality and stability.Development of time-release active ingredients in oral suspensions. Using Wurster Coater to apply either an aqueous or non-aqueous coating over resin particles. Chemically analyzed the coated resins using HPLC instrumentation.

Developed water insoluble particles for contrast media test procedures.Performed necropsies on animal test subjects.