Professional Experience

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Small Molecule Development Engineer

· 28 years developing, scaling up and transferring processes to existing manufacturing facilities. 

· Responsible for developing the chemistry and purification processes to produce new products.

 - Identification of optimum reaction and purification conditions, hazards and safeguards

 - Development of raw material specifications and testing methods

 - Execution of laboratory studies to demonstrate large scale performance

· Responsible for production of new product by identified process in pilot plant  

 - Processing under GMP requirements as products were for human use in clinical trials

 - 24/7 processing requiring supervision of critical operations and troubleshooting upsets

 -  Execution of in-process analytical methods to support processing decisions

· Responsible for  transferring process to manufacturing facilities to produce for sale API

 - Transfer process knowledge to facility, support laboratory reproduction of process

 - Assist in training of operators and provide shift supervision

Large Molecule Development Engineer

· Responsible for developing primary recovery processes to produce new MAb products

 - Identification of optimum disk stack   centrifugation operating conditions

 - Identification of optimum depth filtration train for final clarification

· Responsible for execution of developed recovery processes to produce new MAb products

Global Small and Large Molecule Engineering Consultant

· Provided support for both small and large molecule processes throughout the company and to   contract manufacturing organization

Small Molecule Development Engineer

· Identified, developed and scaled up batch fractional distillation to allow safe purification of a   thermally unstable intermediate

· Developed crystallization conditions which prevented attrition of a rod habit product which had   previously proven to be unsuitable for filtering centrifuge isolation

· Developed and scaled up multiple ozonolysis processes from bench to full scale manufacturing.   Procured   ozone generators and air preparation equipment, designed ozone generator room   layout and piping, supervised installation and start up of the equipment. 

Large Molecule Development Engineer

· Developed a pH controlled broth treatment process which doubled the capacity of current   production depth filtration train

· Identified and implemented a higher capacity depth filtration train for MAb primary recovery. 

Global Small Engineering Consultant and Large Molecule

· Developed and scaled up an isolation/purification process for a new fermentation produced   protein product utilizing broth treatment, disk stack centrifugation and ultrafiltration

· Repurposed an idle ultrafiltration skid for use as a microfiltration skid with a savings of $400k

· Principle role in design of nanofiltration skid for use by contract manufacturer

· Executed studies to demonstrate suitable sheet format ultrafiltration membranes as   replacements for existing insulin manufacturing process using obsolete spiral format devices