• Oversees complex cell and gene therapy drug product process development efforts as a technical lead within a cross-functional team• Leading early and late-stage projects within the drug product unit to enhance manufacturing gene therapy technologies, capabilities, and processes.• Technical SME for fill/finish technology transfer, drug device and manufacturing process technical support for both internally and externally produced pre-clinical and clinical cell and gene therapy products.• Designing and executing of in-house drug product-related experiments including particulate assesment, device compatibility, and other drug product studies.• Managing experimental activities at CDMOs including leachable/extractable studies, container closure studies, filtration development/validation, and other drug-product related studies/testing.• Reviewing and approving manufacturing documentation (batch records, SOPs, protocols) as needed.• Authoring and reviewing relevant drug product CMC sections for global regulatory submissions- collaborating with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidance.• Strong knowledge of all aspects of cell and gene therapy drug product development with applied experience in formulation design (DoE) and development.• Leading efforts to build a drug product lab to support new technology assessment around CAR-T therapy

• Investigated brain drug delivery activities of ASO products by using sustained and targeted delivery technologies through CROs and in-house projects.• Supported drug discovery by designing and preparing formulations to support pre-clinical in-vivo pharmacokinetics, efficacy and toxicity studies.• Developed lipid and polymeric nanoparticles, assessed in-vitro release dynamics using Sotax USB IV and supported quantification of drug content in-vivo.• Extensive experience in chemical conjugation, surface modification and particle characterization.• Investigated Intrathecal device technologies, assessed dose recovery and compatibility studies for ASOs and drafted reports for IND/NDA submission.• Developed lyophilization cycles to improve product quality of ASOs.• Designed platform documentation strategy by drafting reports to assess E&L, glass delamination, and container closure integrity activities for ASO modality.• Executed of fill-finish process characterization studies such as mixing, filtration and aseptic filling.• Represented drug product in CMC development teams and supported regulatory filings as necessary.• Thorough knowledge of drug product manufacturing process flow and operations such as mixing, sterile filtration and container filling/stoppering.

Chemical Engineering, Advanced Drug Delivery Research Laboratory, mentor Dr. Rebecca CarrierThesis Topic: Food-Associated Stimuli Enhance Barrier Properties of Mucus• Developed and enhanced “Multiple Particle Tracking, MPT” methodology to characterize impact of food-associated lipids and physicochemical stimuli (including ionic salts and pH) on scraped porcine, wild type mice (ex-vivo).• Developed an in-vivo surgery protocol to investigate intestinal mucus barrier properties change of rats upon exposure to food-associated stimuli.• Small molecule (model drugs and nutrients) kinetic profiles in porcine mucus were characterized using a novel spectroscopic technique ‘Electron paramagnetic resonance’ (EPR).• Applied lipid based formulations for oral drug delivery to explore kinetic profiles of drugs in GI tract.• Special coatings of drug carriers were processed to make drugs resistant to the stomach acids and to disintegrate in the small intestine.• Analyzed FTIR spectra to assess the degree of change in the local environment of mucus after exposure to food using Multivariate Data analysis (leading edge software) method. • Premature intestinal mucus barriers was “strengthened” at the time of feeding using safe, natural, synergistic factors (chemical enhancement agents) that modulate mucus barrier properties.• Effective drug carrier transport in bovine eyes through vitreous humor investigated using MPT.

• Investigated defective mechanism of mucus in Hirschsprung’s Disease (abnormality of the nervous system which causes absence of peristalsis, hypertrophy, and dilation of the colon) against particle transport and microbe invasion.

• Investigated the diffusion coefficients and associated approximate times for traversal of food-associated bile salt micelles from a physiologically relevant mucus layer by using Fluorescence Recovery After Photobleach (FRAP).

• Investigated the impact of food-associated lipids and associated intestinal physicochemical changes on pathogen transport in small intestine by using video microscopy.

• Column chromatography and caesium chloride density-gradient ultracentrifugation techniques applied to purify native pig gastric mucus.