Watertown, Massachusetts, United States
I graduated from Carnegie Mellon University with honors majoring in Chemical Engineering with a double major in Engineering and Public Policy receiving a 3.8/4.0 QPA. By my sophomore year, I became extremely interested in biological engineering and nanotechnology. My first job in the biotech industry was at Pall Corporation in their Life Sciences division. I performed benchmark tests on prototype, next-gen, and competitor ultrafiltration membranes in order to map out the properties of the membrane. I then moved on to an exciting opportunity at Biogen evaluating the ability of Acoustic Filtration developed by FloDesign Sonics to clarify biopharmaceutical cell cultures in development scale operations. I then took a position at a start-up, PixarBio, a developing downstream purification methods to remove contaminants from the PLGA microparticle formulation and prepare samples for drug formulation of a Non-opioid pain treatment. At Ocular Therapeutix, I was originally involved in a project formulating hydrogel drug delivery systems for protein therapeutics aimed at treating macular degeneration in a partnership with Regeneron. I then developed a treatment for Dry Eye, encapsulating API into a hydrogel network. I lead the design of the process from conception through IND submission. I then moved on to Translate Bio working on mRNA technology for Vaccines and genetic disorders. I helped develop a single-use GMP process for production of mRNA Drug Substance and mRNA encapsulated Lipid Nanoparticles. I lead the execution of over 30 GxP batches. After being acquired by Sanofi, I lead tech transfer to their facility in MLE, France. Additionally, I worked on process scale-up to support Phase 3 and commercialization. My experience and education have made me extremely well rounded intellectually which helps me keep an eye on the big picture while excelling at specific tasks on hand. Specialties: Chemical Engineering, Biopharmaceuticals, Biotechnology, Membrane Science, Filtration, Chromatography, Public Policy, Statistics, Chemistry, Purification, Process Development, DoE, QbD, GLP, GMP
Successfully transitioned to Sanofi after acquisition of Translate Bio. Acted as mRNA Drug Substance subject matter expert (SME) and lead of GPH and Tech Transfer. Transferred mRNA and LNP GMP manufacturing processes to Sanofi Head Quarters in MLE. Scaled up mRNA DS process to support Phase 3 and commercial production and transferred to process to an external CMO.
Developed single-use GMP process for mRNA Drugs Substances and mRNA encapsulated lipid nanoparticles (LNPs) and implemented this process at a CMO. Lead the execution of over 30 GxP batches. Authored MBRs and SOPs. Lead GMP investigations, deviations, CAPAs, Change Controls, etc. Provided hands-on support in process development/scale-up of drug substance and/or product formulation in both cGMP and non cGMP capacities. Assisted in coordinating technology transfer of mRNA and nanoparticle manufacturing processes to CMOs. Managed tech transfer activities to CMO, CRO and CDMO partners Supported and contributed to IND filings/regulatory documentation
- Lead the development of OTX-CSI, a Cyclosporine loaded intracanicular insert. - Implemented QbD principles - Took project from conception to product capable of supporting IND submission and Clinical Trials - Wrote batch records, SOPs, technical documents, and other supporting documents
- Develop novel sustained release hydrogel drug delivery systems for therapeutic proteins to treat macular degeneration of the eye. - Perform formulation and process development studies for novel sustained release drug products - Analyze and evaluate the impact of formulation and process variables on drug product characteristics - Manufacture sustained release drug product prototypes to support preclinical studies - Develop scalable manufacturing processes for critical attribute and process parameter control - Manufacture drug products for early stage clinical studies following GMP production requirements
- Developed downstream purification method for novel non-opioid pain medicine. Developed filtration methods to purify and concentrate microparticles containing biomaterials and APIs. - Optimized & scaled process to reduce costs, processing time and improve yield -Managed development of processes for the purification, fill, & finish of microparticle drug delivery systems. - Oversee technology transfer to CMO - Assist in the construction of cGMP facility to produce product for clinical trials and patients
- Developed downstream purification method for novel non-opioid pain medicine. Developed filtration methods to purify and concentrate microparticles containing biomaterials and APIs. - Optimized & scaled process to reduce costs, processing time and improve yield - Oversee technology transfer to CMO - Assist in the construction of cGMP facility to produce product for clinical trials and patients
• Assessed the ability of Acoustic Filtration developed by FloDesign Sonics to clarify biopharmaceutical cell cultures in development scale operations. • Interfaced with external collaborators via monthly presentations and experimental updates • Evaluated alternative chromatography steps for HCP & DNA removal such as monolith chromatography and membrane adsorbers using a GE AKTA Avant Chromatography system. • Assisted the Process Biochemistry team in pilot scale unit operations including filtration (TFF, DF, ILC) and chromatography.