Commercializing ENHEnS and eLNP biological payload delivery technologies to improve the efficacy of gene therapies through repeat, systemic, and targeted dosing.

Guiding clientele seeking scalable solutions for their lab and pilot scale processes.

Engineering manager of the iLipase development program, coordinating internal and external activities for the submission of a Food Contact Notification (FCN) for Alcresta’s next generation of Immobeads and iLipase. Defined iLipase specifications and managed production of material suitable for use in design verification and validation lots for Alcresta’s next generation RELiZORB medical device. Managed analytical method development and validations to demonstrate Immobeads and iLipase material as suitably pure for use in RELiZORB.Key Accomplishments:• Conducted supplier investigations at multiple suppliers to improve product safety. Implemented process improvements and operational hygiene changes to eliminate >90% of extractable impurities in iLipase, reducing remaining concentrations below threshold of toxicological concern.• Improved enzyme immobilization through process capability studies, reducing enzyme loss from iLipase by 60% while maintaining 30 – 50% improvement in immobilized enzyme activity in simulated use testing.• Transferred Immobead production to newly constructed, dedicated manufacturing facility, managing supplier through the commissioning of all process equipment over a 3-month period without disruption to required production volumes to support commercial launch of next generation RELiZORB.• Performed engineering assessment of iLipase and RELiZORB device testing to define formula residence time requirements for future applications and treatment of an expanded patient population.

Managed small-scale process optimization and troubleshooting studies to support technology transfer to the commercial scale for next generation iLipase, a food contact substance-enzyme complex. Designed and coordinated experiments to support scale-up of production for next generation Immobeads, macroporous polymer beads for immobilizing enzymes. Coordinated engineering study across the entire supply chain to demonstrate design feasibility for the next generation RELiZORB device, a single-use lipid hydrolysis reactor to aid in fat digestion in patients with pancreatic insufficiency (EPI) and short bowel syndrome (SBS).Key Accomplishments:• Managed new Immobeads supplier through commercial scale development, commercial facility construction, and quality management system (QMS) implementation on time and on budget over a compressed 15-month timeline.• Successfully applied DOE to scale-up of suspension polymerization by 3x’s and elutriation operation by 5x’s, increasing overall process yield by 20% and reducing fines in the particle size distribution by 80%.• Managed enzyme immobilization supplier through 2x scale-up of ion exchange chromatography and TFF based enzyme purification process and resolved inconsistencies in iLipase activity with small-scale troubleshooting DOEs.• Resolved iLipase particle aggregation issue induced from triboelectric static charge with formulation adjustment using materials native to the iLipase manufacturing process. • Improved in RELiZORB device filling accuracy through the application of static dissipating ionization equipment, reducing iLipase fill weight variability by 80%.

As R & D Engineer III, I conducted equipment design for process and containment of DepoFoam, a multiple emulsion process with volatile compounds, at the laboratory scale. Executed DepoFoam product development at bench, lab, pilot, and commercial scales. In addition, I provided small-scale experimental technical guidance for commercial EXPAREL product process launch and tested process analytical technologies (PAT) for intermediate and product characterizations.Key Accomplishments:• Mapped and operationalized self-contained lab space, process isolators, and clean-in-place capable production equipment for developing DepoFoam products for HPAPI with capital expenditure of less than $500k in one year.• Designed and implemented wash-in-place system for lab-scale vessels to mitigate HPAPI-related risk in cleaning procedures at a scale 3x’s smaller in volume than is conventionally considered viable.• Applied Quality-by-Design (QBD) principles in product development, using DOEs to review process spaces and fortify three DepoFoam Pipeline products all in one year.• Started fresh process design to align existing product attributes with EXPAREL commercial product, allowing new capabilities by either yielding 50% greater potency with tunable release rate, or 50% more product with similar performance.

As R&D Engineer II, I delineated DepoFoam product processes at bench and lab levels, deployed CFD model design for continuous DepoFoam stages, and incorporated sound principles for toxicological and clinical trial research of materials for market expansion.Key Accomplishments:• Reformulated DepoMLX product process to double potency of initially transferred formulation with severe processing issues at higher potency in six months.• Drove new process launch to scale and configured commercial scale equipment in subsequent three months.• Engineered development and production stages of clinical trial materials for DepoTXA pipeline product, scaling new product, developing process at scale, and leading production of clinical trial materials within six months of starting role.

As Research Chemical Engineer, I defined gas disperser and dryer geometric design principles and prototyping for modular and deployable spray dryers. I also influenced development of polymeric nanoscale dispersions for HPMCAS pseudolatex capsule production. Key Accomplishments:• Engaged in atomizer design research and model development for flash nozzle spray drying.• Facilitated scale-up and equipment design for pilot and commercial spray drying suites and completed pharmaceutical spray drying process improvements.• Coded scripts and defined algorithm research for motion sensor data analytics for Nike+ products.• Architected, prototyped, and implemented novel spray dryer design for rapid usage; dryer produces equivalent amounts of product across existing platforms with 50% of normal operating footprint.• Transformed Niro PSD-2 spray drying platform to double throughput vs. conventional operations, also introducing innovative 3D printed secondary cyclone system to prolong usability of downstream process filter.

As Engineering Intern, I completed seasonal internships accumulating 12 months of lab experience prototyping Modular Automated Sampling Technology (MAST), automating aseptic vaccine bag filling machine procedures for non-sterile environments, and sequencing algorithms to maximize automated buffer production.Key Accomplishments:• Contributed to prototype design and reliability testing of Modular Aseptic Sampling Technology; enabling increased aseptic sampling rate frequency, reduced to every 30 minutes from typical 4 to 8 hours.