Formulation scientist / September, 2025 — Present

Planned and executed technology transfer activities from RD to pilot clinical and commercial manufacturing sites including preparation of tech transfer protocols risk assessments and transfer reports. Provided technical leadership and oversight to CMOsCSPs for formulation development scale-up GMP clinical trial manufacturing and troubleshooting. Analyzed and interpreted formulation stability and process data to drive formulation optimization comparability and control strategy development. Authored reviewed and supported drug product CMC sections of INDs NDAs and IMPDs including formulation composition manufacturing processes and change impact assessments. Reviewed and approved manufacturing batch records formulation development reports and CMO documentation ensuring GMP compliance and regulatory inspection readiness. Overseen clinical trial material (CTM) manufacturing inventory management of raw materials and finished products and cross-functional coordination with Quality Regulatory and Supply Chain teams.

Quality and Regulatory Associate Scientist / February, 2024 — June, 2025

Managed quality management systems including developing work instructions and SOPs data collection analysis and reporting ensuring compliance with established protocols for a Class II medical device. Prepared Researcher License Inspection requirements and audit readiness documentation for Massachusetts state securing Researcher Controlled Substance Registration for antibiotic clinical usage. Researched and compiled a detailed competitor matrix for ID and AST instrumentation evaluating systems across critical parameters including technology performance and cost delivering actionable insights for market assessment. Conducted comprehensive patent landscape analysis for novel ID AST technologies directly influencing MRDPRD specifications and guiding RD towards innovative non-infringing solutions. Implemented R Space (ELN) for systematic documentation of design phases experiment protocols and validation results significantly improving data traceability and ensuring ISO 13485 documentation standards during quality audits saving 30 manual hoursweek. Conducted SIR (Susceptible Intermediate Resistant) interpretation of AST results using current antimicrobials for sepsis-related microbes improving diagnostic turnaround time.

Formulation RD Scientist / January, 2023 — December, 2023

Successfully enhanced nanoparticle synthesis characterization and formulation processes advancing therapeutic applications through DOE and optimization. Conducted analytical assays (fluorescence-based assays HPLC) to generate stability information that led to the selection of the top three formulation candidates for further development. Established highly effective ex vivo tissue assays leveraging literature reviews experimental design and iterative refinement in the characterization of Glucose absorption as a model of its retardation in a preclinical porcine tissue. Planned and conducted in vivo studies (porcine and rodent) to improve understanding of drug safety and efficacy profiles including testing of top formulationtablet prototypes. Preparation and review of all CMC sections of regulatory submissions including INDs IMPDs Study Progress reports and amendments. Performed downstream unit operations to support the manufacturing process of oral solids. Performed dosage form characterization utilizing methods such as particle size analysis hardness friability powder flow disintegration and dissolution.

Sr. Research Scientist / July, 2017 — March, 2022

Managed external teams and provided technical direction to contract manufacturers for oral liquid and topical prototypes overseeing scale-up production. Participated in regular cross-functional meetings collaborating with Regulatory and Legal teams to interpret technical patents and develop strategies for 505 (j) and 505(b)(2) products. Supported the commercialization of new technologies by developing novel compositions and overseeing the successful technical transfer and scale-up of skincare and oral dose products. Developed enteric-coated tablets using methacrylic acid copolymers to enable targeted release of polymer in the upper small intestine enhancing stability and site-specific bioavailability. Collaborated with Regulatory and Legal teams to interpret technical patents and develop strategies for 505(j) and 505(b)(2) submissions. Developed scientific support for product quality monitored stability studies for OOSOOT occurrences and implemented corrective actions to ensure adherence to cGMP standards. Applied in-depth knowledge and leading oral liquid and topical dosage forms to the successful development and scale-up production.

Research Executive / August, 2016 — July, 2017

Strategically utilized Design of Experiments (DOE) to develop and optimize stable robust formulations for Antibiotic and Anti-convulsive Oral Suspensions significantly enhancing product stability optimizing excipient ratios and ensuring target bioavailability for commercial success. Led cross-functional team in the RD and scale-up of a complex multi-active topical ointment formulation (anti-fungal anti-bacterial steroid and biopolymer) successfully transitioning the lab prototype to a commercially viable and stable production-scale formula. Successfully formulated challenging low-dose topical formulations (e.g. immunosuppressant ointments) requiring precision compounding and meticulous process control to ensure content uniformity and therapeutic efficacy. Managed and directed artwork design and packaging development for new products ensuring strict alignment with international regulatory standards and collaborating with Regulatory Affairs to streamline the product development lifecycle. Directed the RD pipeline strategy by independently preparing and presenting detailed quarterly justification and interim product development reports providing crucial oversight that shaped the direction of future research and resource allocation.

Research Associate / August, 2016 — July, 2017

Led the development and scale-up of Oral solids topical dosage forms and Oral suspensions. Supported technical transfer activities by preparing and authoring all necessary documentation for process validation batches including Hold Study Protocols BMRs and PDRs. Ensured compliance with Quality Systems in a cGMP environment by monitoring process optimization and ensuring adherence to protocols during scale-up to commercial manufacturing. Developed a high-concentration powder drink mix for nutritional supplements optimized blending parameters and particle size distribution by granulation to improve flowability and prevent moisture uptake resulting in a highly stable non-clumping powder with excellent dispersibility meeting sensory and shelf-life targets. Developed and revised Master Manufacturing Records (MMR) with precise weighing and blending instructions. Established consistent production runs compliant with 21 CFR Part 111.