William Thach Email & Phone Number

• Process Engineering Lead for Downstream Processing Flu and Pandemic Vaccine Project • Previously Process Engineering System Owner• Technical issue resolution: Developed and reviewed technical solutions/design changes, attained endorsement from involved functions, and coordinated with vendor to implement changes• Change management - preparation and presentation of change requests to project management stakeholders• Vendor management - Management of deliverables, design, change requests, accounting, installation, schedule between vendor and other project functions

Toronto, Canada Area

• Installation qualification, operational qualification and performance qualification of process equipment for a GMP plant expansion project• Completion of process development and consistency lots leading to FDA and Health Canada licensure• Site acceptance test protocol development and execution (tuning of control loops, validation of equipment modules and process operations)• Developed batch production record for new production area• Established and executed on key operational priorities as a change control and deviation leader leading to regulatory adherence, critical safety improvements, cost savings, streamlined documentation and increased process efficiencies • Trained in GMP, GDP and GLP

Ottawa, Canada

• Successful development of an NMR fingerprint assay for the conformational assessment of bio-therapeutics for the regulation of subsequent entry biologics (SEB) (SEB's are biosimilar therapeutics seeking market authorization upon the expiration of patent protection of the innovator drug)

Guelph, Ontario

• Designed and assembled automated chemical analysis testing instrumentation• Programmed chemical analyses for clients, e.g. wastewater alkalinity testing, silver determination• Systematically problem solved issues in application development

Brantford, Ontario

• Performed analytical chemical testing on raw materials, intermediates and finished goods (candle wax and carpet cleaner) to assess quality of product• Documented records of lab operations (test results, chemical analyses and instrument calibrations) in accordance to ISO standards using SAP• Initiated an independent project to develop a quality control method to assess the concentration of the active ingredient in an odour-eliminating aerosol product• Verified the repeatability and reproducibility of the aforementioned method which was subsequently incorporated as a SOP

Masters Of Engineering, Chemical Engineering

Msc., Biochemistry