Developed and optimized a commercial manufacturing process involving in-line homogenization of a solid-in-oil suspension; increased production volumes from 2L to 400L.Led the fielding and selection of a Contract Manufacturing Organization (CMO) for commercial-scale manufacturing.Established a new Quality Management System (QMS); drafted Quality documents and managed a team of Quality consultants.Managed client relations and served as a front-room technical lead during audits.Drafted and executed Equipment Qualifications (IQ/OQ/PQ) for manufacturing and analytical equipment.Co-managed a team of 3 engineers and 2 co-ops in executing production runs and drafting quality documents including SOPs, batch records, analytical test methods, and validation protocols.Served as Project Manager and client face for a commercialization project; developed project timelines and oversaw client communications.

Managed the tech transfer, batch record generation, equipment ordering & machinability, and cGMP manufacturing for drug products utilizing both vial and syringe filling lines.Scaled a commercial syringe-filled drug product manufacturing process to 30,000 units (6-fold increase) per run, including developing novel CIP & SIP processes.Wrote and reviewed GMP documents including batch records, SOPs, CAPAs, change controls, and investigations.Provided hands-on instruction and support to a team of more than 20 manufacturing technicians to onboard two cGMP manufacturing processes to AMRI’s aseptic manufacturing suite.Served as the primary technical expert on client calls, and communicated directly to clients on any technical or operational questions.

Established a complete manufacturing process for microparticle solvent-evaporation fabrication, tangential flow filtration purification, and lyophilization.Piloted a team of engineers in planning experiments, reviewing data, establishing & meeting timelines, and overcoming work-related challenges. Drafted and edited two patents covering polymeric microparticles for treatment of post-operative pain and epilepsy.Outlined a 10,000 ft2 clean room space for cGMP microparticle manufacturing and fill-finish, including acquisition and layout of equipment and facilities.

Scaled a solvent-evaporation fabrication process utilizing emulsification under high shear stirring for microparticle manufacturing from bench-top to full-scale manufacturing.Established methods for utilizing high-shear stirring to scale the size of vortexes used in emulsification to generate microparticle with high yield, high drug-loading, and low polydispersity.

Developed drug-eluting biodegradable sutures for long-duration local analgesic response. Improved mechanical strength and release profile of sutures, and was able to achieve enhanced local analgesic effect through drug co-release.Fabricated surface-modified liposomes for extended nerve blockage via the Bier-block analgesic procedure. Improved duration and strength of nerve-block through liposomal injection into a rat-model.Augmented antibody-coated silicone tubing for blood filtration of specific cytokines for the treatment of sepsis by optimizing surface modification of tubing and analyzing protein binding rate in a rat ECMO model.