Objective
Seeking a position where I may leverage my process development, project management and engineering management experience while applying engineering principles and problem-solving skills to optimize product performance.
Work Experience
Process Engineering Manager (Manufacturing)
Cohera Medical Inc., Pittsburgh, PA May 2013 – Current
Directly responsible for management of external contract manufacturers including GMP production of bulk product, process scale-up and development, and project management. Reported directly to VP of Manufacturing for project management and development updates.
Key point of contact for all technology transfer from R&D activities to full scale implementation.
Successfully executed process validation for TissuGlu® bulk adhesive synthesis, including IQ/OQ/PQ.
Responsible for driving timelines to meet company core goals including quarterly strategic milestones.
Reverse engineered and re-centered TissuGlu® bulk adhesive synthesis to conform to complaints made by end-user in the field. Developed a mathematical and statistical model to revise critical process parameters to comply with 95%/95% tolerance intervals. Model was successfully implemented on first revalidation run with bulk product meeting specification.
Managed pilot scale and manufacturing scale budgets for capital equipment, process development batches and GMP production. Reduced production costs and improved overall product quality through engineering principles, DOEs and innovative technology such as in-process near infrared (NIR) equipment. Optimized product performance by identifying and maximizing API compounds.
Directly supported the creation of the PMA manufacturing module and submission to the FDA
Scaled up Cohera Medical’s second patented product, bowel sealant. Re-formulated sealant chemistry to exclude needs of catalyst and superfluous solvent. Incorporated three in-process monitoring analyses to optimize desired product concentration, performance testing and physical consistency. Scaled process and batch size from benchtop to pilot plant scale to commercial scale. Designed custom reactor and all ancillary equipment supporting bulk synthesis.
Implemented a supply-chain for extremely hydrophilic sealant including design and installation of custom filling and packaging process under a humidity controlled environment.
Worked closely with or managed process engineers, project managers, plant managers, lab managers, business development personnel, chemists, analytical/QC chemists, research associates, research co-ops.
Process Engineer (Manufacturing)
Cohera Medical Inc., Pittsburgh, PA May 2011 – May 2013
Re-designed synthesis process for pre-polymer adhesive removing catalyst and eliminating risk of runaway reactions.
Developed and scaled-up synthesis process at benchtop, pilot plant and commercial scales. Transferred technology to new contract manufacturer reducing COGS by 60%.
Incorporated unique in-process monitoring method to ensure synthesis robustness and performance. Raised batch acceptance from 60% to 100% with a 98% off reactor yield and increased shelf-life.
Managed all external manufacturing scale-up activities from process development through execution of GMP lots for clinical trials, commercial sales and process validation.
Optimized reactor equipment, tumbling system, transfer tanks and filling process parameters to stabilize and homogenize final product for filling into primary storage container.
Product Development Engineer (R&D)
Cohera Medical Inc., Pittsburgh PA May 2009 – May 2011
Designed and executed extractable and leachable studies, chemical characterization testing, toxicology, sterilization validation, in-vitro degradation and materials compatibility studies for prepolymer adhesives. Test strategy and methods reduced overall project cost by $300K.
Synthesized various formulations of adhesives in an R&D lab as a DOE for final formulation.
Integrated tissue engineering principles to test methods that generated optimal adhesive formulation.
Managed R&D analytical chemistry projects working closely with multiple external vendors.
Trained surgeons for biocomp...
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