Managed and performed testing of Bictegravir and Selonsertib API and drug products to support process chemistry and formulations.• Collaborated with formulations to provide analytical support for manufacturing DOE, bulk hold, and tablet defect studies. Coordinated testing and tracked results from contract testing and manufacturing sites.• Developed UPLC and water content methods for raw and backup regulated starting materials. Preformed dissolution testing on stability samples for packaging configuration and permissible water content studies. • Ensured timely testing and accurate reporting of spike, fate and purge OVI and RS results to process chemistry for API manufacturing process optimization and NDA filing.

Headed the analytical development team for characterization and manufacture of silicone based drug eluting vaginal rings. • Implemented a predictive drug release model using the Higuchi-Roseman equation to reduce dissolution testing time, instrument usage, and chemical waste generation. Optimized the data analysis to eliminate sources of experimental error, improving prediction accuracy. Designed verification process and authored technical report.• Directed the transfer of chemical and physical characterization methods from customer. Wrote transfer protocols, reports and final test methods for assay, impurities, dissolution, tensile, and compression. • Oversaw PAT methodology development for in-line drug substance monitoring as a manufacturing scale up process improvement.• Collaborated with senior staff to create initial drug product and excipient quality systems in compliance with 21 CFR Parts 210/211 and IPEC requirements.

Managed three analysts in the development and validation of analytical test methods. Served key role as analytical representative on cross-functional product development teams. Developed appropriate test methods, providing results to meet project goals and resourcing, budgeting, and timelines. • Directed and performed method development and validation activities to characterize protein-HA cross-linked hydrogels, including total protein content, total HA content, quantitation of cross-linking chemistry residuals, and protein raw material characterization.• Characterized hydrogel products, silicone breast implants, and quantitate residual impurities using chemical and physiochemical methodologies (HPLC/UPLC, SEC-MALS, LC/MS, TOC, FTIR, SEM, DSC, DLS, UV-Vis).• Wrote SOP, instrument procedures, test methods, and technical reports to support product development, regulatory filings, and manufacturing process improvements. Validated laboratory computerized systems and LabNote electronic notebook application.

Directed daily activities of analytical chemistry laboratory, including managing direct reports and external group users, interpreting test results, coordinating instrument and analyst time, serving as SME for training, and ensuring proper use and maintenance of instrumentation.• Conducted and managed the development of analytical methods (HPLC, SEC, GC, DLS, AAA) for characterization of novel PEA-based polymers. Determined drug loading, particle size, percent polymer content, and residual solvents in complex nanoparticle formulations. Formulations consisted of polymer nanoparticles with various therapeutic and diagnostic compounds (paclitaxel, docetaxel, rapamycin, bupivacaine, indocyanine green, insulin). • Developed SEC-HPLC, RP-HPLC, and AAA methods to aid characterization of recombinant hemagglutinin and nucleoprotein for development of influenza A vaccine formulations stable at room temperature.

Managed R&D projects that developed new API and parenteral drug products and ensured compliance with cGMP/GLP regulations for various external customers. Directed six research associates, wrote project quotes and test protocols, and conducted laboratory experiments that ranged from method development to release and stability testing. Continually communicated experimental progress to customers and issued technical reports/CofA upon completion of each project phase. • Developed stability testing programs for API and drug products at all phases of development. • Developed and validated analytical test methods per ICH guidelines and USP requirements for small molecule, peptide, protein, and carbohydrate API and drug products. • Performed drug-excipient compatibility screening and prototype formulation development. Determined sample compatibility with various fill surfaces and closure systems, performed scale-up and lyophilization cycle development, and facilitated technical transfer activities to clinical manufacturing sites.• Conducted parenteral drug product development of radioactive pharmaceutical using the radioisotope 99mTc, including selection of compatible GRAS excipients (reducing agent, bulking agent, trans-chelator, pH adjustor), development of radiopurity assays (HPLC, ITLC), and lyophilization cycle optimization. Project reports bolstered customer's CMC filing to release drug product from clinical hold. Composed portion of stability section (CMC, Section V) for customer's IND filing. • Created analytical test method using HPLC for potency and purity testing of peptide API, including screening various reverse phase columns and mobile phases.• Conducted forced degradation study of protein parenteral drug product. Determined degradation profiles by SEC-HPLC, IEC, or RP-HPLC. Fractions of degraded samples were collected and characterized by SDS-PAGE and IEF as orthogonal methods.