Coordinated cross-functional teams to author and review electronic Common Technical Document (eCTD) Module 3 sections for an average of 35 CMC regulatory submissions annually.• Engineered and implemented a streamlined business process for the technical writing group allowing the team to successfully manage over 75 CMC regulatory submissions across both clinical and commercial cell therapy products.• Championed the use of Smartsheet within the technical writing team, delivering comprehensive training that enhanced tracking and management of critical CMC regulatory submission timelines.• Functioned as project manager to facilitate collaboration among cross-functional teams to ensure timely authoring and review of CMC regulatory submissions.• Partnered with subject matter experts to author or co-author Module 3 sections, enabling subject matter experts to concentrate on technical responsibilities while still ensuring high-quality documentation.

Guided the product lifecycle CMC team to achieve target timelines in the final stages prior to commercial approval, culminating in a successful and timely biologics license application (BLA) submission. • Coordinated project timelines and resources using MS Project and Smartsheet, ensuring alignment with target deadlines and driving the team toward on-time delivery.

Directed a cross-functional team in the successful validation of 9 analytical Quality Control (QC) methods within 9 months, facilitating the initiation of drug product process validation and ensuring timely BLA submission. • Developed a robust analytical method validation process in Analytical R&D that adhered to health authority and regulatory guidelines, providing a framework for future method validations.• Oversaw the prompt resolution of deviations and investigations during analytical method validation studies, ensuring adherence to timelines and maintaining project momentum.• Cultivated cross-functional collaboration among the method validation, method characterization, QC, and Quality Assurance teams, enhancing teamwork and efficiency.• Prepared the analytical team to represent Analytical R&D as subject matter experts for analytical method validations for health authority pre-license inspections. • Authored and reviewed analytical eCTD sections for drug product and drug substance, contributing to the successful BLA filing.

Established a high-performing 5-member team to drive method validation activities in preparation for validation of 9 analytical methods.• Chosen to lead the analytical method validation project for a CAR T cell therapy, successfully validating 9 analytical methods. • Designed validation parameter studies for QC methods, including flow cytometry, cell concentration, enzyme-linked immunosorbent assay (ELISA), and safety tests, ensuring thorough preparation for method validation. • Collaborated with the Analytical Characterization team to effectively characterize analytical methods by using design of experiment (DOE), data analysis, and statistical tools (Minitab, JMP), optimizing qualified release methods.• Integrated regulatory guidelines (FDA, EMA, JP, USP, Ph. Eur., etc.) into QC methods to ensure compliance with industry standards. • Enhanced project management skills by co-managing a cellular immunotherapy CMC team for a six-month period, applying strategic knowledge to streamline operations and ensuring focused leadership and timely execution. • Coordinated the writing of the Investigational New Drug (IND) Module 3 CMC section for a novel cellular immunotherapy, facilitating an expedited IND submission by one quarter. • Authored IND Module 3 analytical method sections for a CAR T cell therapy, contributing to the on-time IND submission.

Developed, qualified, and transferred (to QC) multiple methods for identity, purity, viability, cell health, and cell concentration to assess clinical cell therapy product, ensuring high-quality results for Process Development (PD) experiments.• Created assays utilizing various platforms (cell-based, flow cytometry) to evaluate cell health, supporting both PD experiments and long-term/post-thaw stability programs.• Proposed and implemented enhancements to flow cytometry method in collaboration with external partners and implemented the improved method into the QC department.• Established and executed an analytical assay support program in QC, optimizing and structuring analytical testing and reporting for PD samples. • Trained QC analysts to perform assays for the analytical assay support program and method qualifications, ensuring consistent quality and reliability in testing methods.• Co-designed and implemented an electronic laboratory notebook (ELN) in partnership with corporate IT, transitioning the development division from paper-based to electronic data recording to enhance efficiency.• Served as subject matter expert and primary contact for the ELN, facilitating ease of use over a six-year period.

Developed and optimized analytical methods by utilizing DOE to rigorously evaluate assay robustness for flow cytometry identity and cell health methods. • Designed and executed experiments to assess the stability-indicating potential of a matrix of cell health assays. • Implemented statistical software (Minitab) in QC and AR&D to effectively track and trend assay control and system suitability data, providing a framework for the future. • Facilitated weekly failure modes and effects analysis (FMEA) meetings, systematically identifying and ranking failure modes in the Clinical Production Drug Product process to enhance operational safety and efficiency.

Managed creation of SOPs for transfer of parent company pipeline product testing methods to QC department. Created and revised specification worksheets and product specifications for drug substances, drug products, finished goods, and interim reference standards for pipeline products. Supported QC Analytics group by performing SE HPLC assays to determine molecular weight and purity of pipeline products. Assessed feasibility of performing residual assay by means of reverse-phase HPLC method from parent company in the QC Analytics group.

- Performed purification of DNA from laboratory cell lines and immunostaining of melanoma cells.- Prepared and submitted DNA samples for microsatellite testing and mutation analysis to ascertain if cell lines are contaminated.- Maintained melanocyte and melanoma cell lines.- Performed Western blot technique to analyze protein expression in signaling transduction pathways when protein kinase inhibitors were applied to melanoma cells.- Collected, lysed, and prepared cell samples for Western blotting and for flow cytometry.- Evaluated cell viability via MTT assay.- Prepared reagents necessary for laboratory use.

- Examined the cell proliferation/survival pathways within melanoma cells (resistant to a BRAF inhibitor) by blocking particular receptor tyrosine kinases.- Investigated the alteration in protein expression in these pathways via Western blot technique.

- Generated data set that will aid in future selection of alternative/substitute cryogenic storage bag for products.- Evaluated different properties of these bags to determine suitability/compatibility with current process.- Conducted cell aggregation assay.

Utilized Waters Alliance HPLC System for affinity chromatography to determine concentration of pipeline monoclonal antibodies products and SE HPLC to determine relative molecular weight for Commercial/Clinical Manufacturing and PD. Performed UV-Vis spectrophotometry to measure protein concentration, as well as Visual Appearance testing of drug substances/products, in support of Manufacturing, QC Stability, and PD. Verified paperwork related to weekly Stability pulls. Prepared and discarded (as needed) formula-specific buffers/mobile phases used in daily laboratory assays for each commercial/pipeline product. Calibrated and maintained laboratory equipment.

Served as the principal liaison between QC Stability and QC Biochemistry departments by receiving, preparing aliquots of, and distributing clinical, commercial, stability, and PD samples. Interfaced with various departments to inform sample submitters of progress of QC testing. Archived QC raw data, compiled QA data packages, and assisted in revision of pertinent SOPs/forms. Maintained and organized Sample Accession Lab by routinely ordering supplies and discarding previous samples stored in temperature-controlled units. Functioned as LIMS Subject Matter Expert for Sample Coordination and trained personnel in applicable job functions.

- Explored antimicrobial activity of products produced by probiotic Lactobacillus casei Shirota by conducting well diffusion/inhibition assays. - Quantified overall amounts of lactic acid produced via enzymatic assay.- Utilized native PAGE and SDS-PAGE to isolate antimicrobial peptide from concentrated supernatant. - Analyzed toxicity effects of L. casei supernatant on vaginal tissues via MTT assay.- Made and autoclaved media for use in experiments.