Consulted in drug substance manufacturing on starting materials sourcing and contractor selection. Contractor selection and process improvement on sterile drug product manufacturing.

*Responsible for manufacturing and technical improvements for Eisai outsourced drug products: solid and liquid oral dosage forms, sterile/lyophilized products, and a syringe product. *In-house expert on all outsourced drug products.*Technical trouble shooting, process improvements, validation, writing CMC submissions. *Working with US, Canadian and European CMOs and Eisai personnel in Japan.*Reduced product water content for a lyophilized product by statistically analyzing operating data, that led to use of a consistent tray loading pattern in the lyo. *Prepared PAS submissions for a new autoclave and major revamp of a CMOs grade A & C manufacturing area. *Prepared PAS submissions to eliminate 2 IPC tests for a lyo'ed product.*Led efforts to eliminate foreign matter in a sterile fill product.

Wrote RFQs to outsource drug substance and an oral anti-coagulant drug product manufacturing for Phase I and Phase III clinical trials. Audited contractors. Performed bid analyses and negotiated contract details. Conducted technical transfer and supervised manufacture on-site.Outsourced drug substance manufacturing to US, British and Irish firms.Successfully scaled-up a liquid drug product from 500mL to 1800L.Qualified a laboratory facility for GMP manufacturing. Wrote IQ/OQ protocols and cleaning procedures for 12, 22 and 50-liter equipment.Scaled-up 3 drug substance manufacturing processes from 12 or 22 liters to 200 - 1000 gallons within a year.

SR PHARMACEUTICAL SCIENTIST 1991-1998•Assigned difficult and high profile manufacturing issues for resolution via use of statistical techniques and/or laboratory studies. Examples:*Tableted product: 10% of batches would not meet hardness on compression & 33% failed potency. Revised granulation to eliminate both issues. *Tableted Product: 50% of batches failed dissolution. Implemented granulation endpoint determination via power consumption. This eliminated dissolution failures. * Determined cause of erratic alcohol stability for a liquid antibiotic as poor agitation. Evaluated other agitators on-hand for and selected 2 that produced a liquid with satisfactory stability, avoiding a possible recall.• Supervision of one to three scientists or engineers. Managed Technical Service’s Dept. in-process testing laboratory. • Supervised or conducted approximately one dozen process validation projects including tablets, capsules, liquids & ointment dosage forms.MANUFACTURING SUPERVISOR 1989-1991•Managed a 40mt/yr Piperacillin Monohydrate (precursor for Pipracil™) facility. Product had sales of $150MM/yr.•Responsible for developing facility budget of $7MM/yr.•Supervised a diverse staff of nine: one professional and eight technicians.•Maintained facility so it would pass FDA audits, corporate safety, environmental and GMP inspections. Facility never received a 483 citation.PROCESS ENGINEER 1987-1989•Technical improvements and process optimization on the Piperacillin Monohydrate manufacturing facility. Improved yield by 7% over 4 years (Note: 1% yield increase = $225K/yr.) and reduced product color by 50%, both with no capital expenditures.•Successfully scaled-up a solvent recovery process by performing distillations at a 750-gallon scale. Supervised design, construction, start-up and operation of the 2000-gallon full-scale facility.