In this role, I served as the only immune cells SME across the Cell Culture Technologies within Sartorius which included defining and leading the workflow strategy to develop process solutions through innovations made to the existing products, software, and services – and/or development of new products to address the market demand and new trends.As for my key accomplishment in this role, I: - Created comprehensive process mapping for various immune cell manufacturing processes including CAR-T, TCR-T, TIL, CAR-NK and Dendric cells.As for my key responsibilities in this role, I: - Led the segment business strategy by working with cross functional teams across different company divisions to define and execute on the segment business strategy. - Served as the point of reference and source of truth for immune cells processes. Provided ongoing presentations and trainings on the process flow, the science behind, process pain points, and areas for improvement. - Scouted and evaluated a wide range of applicable technologies. Made technical decision to recommend for or against pursuing technologies for potential acquisition by Sartorius. - Provided ongoing trainings for cross functional teams to increase knowledge on immune cell processes from R&D to manufacturing, their objectives and challenges. - Worked closely with the sales team to increase customer satisfaction and improving the products positioning. - Worked closely with the product management teams across different departments to design new products in cell culture technologies, separation technologies and fluid management technologies. - Built process knowledge and technical expertise for the company through process mapping and Cost of Goods Sold (COGS) modeling.

In this role, I served as the lead process development scientist for the company's first preclinical drug product to design and optimize a closed end-to-end process for tech transfer and implementation in manufacturing. In addition, I served as the SME for the bioreactor operations at Lyell which included installation of new equipment in PD, training of staff in PD and manufacturing on use of the bioreactors, troubleshooting technical issues, process improvement and optimization. For my key accomplishment in this role, I:- Implemented process improvements to increase the yield of a TCR product on the expansion process by 30% and final drug product formulation by 50% while maintaining the quality of the drug product.As part of my key responsibilities, I: - Authored technical reports including process development report, process description, process characterization master plan, Process Control Strategy, and process risk assessment (FMEA). Authored sections of IND filing. - Worked with cross functional teams to design and optimize closed end-to-end processes for different drug products. - Evaluated a wide range applicable technologies for process improvement including cell selection, PAT, data analytics, formulation, and fill and finish for process improvement and optimization. - Performed DoE and statistical modeling. Provided ongoing statistics and JMP training to other scientists and engineers. - Served as the only subject matter expert on bioreactor operations. Designed and optimized T-Cell and HEK293 (viral vector) expansion protocols. Provided bioreactor training to new employees. - Worked closely with the Information Sciences and IT teams to implement real-time process monitoring and an on-line cloud based statistical process control tool.- Served as the Lean Champion across the Process Sciences group which included leading the implementation of 5S in the laboratories, Inventory management and forecasting, and risk management.

In this role, I served as the subject matter expert for cell and gene therapy applications, offering technical pre-sales support and consulting with clients in the “regenerative medicine” marketing segment as well as post-sales support such as offering training on operating different bioreactor systems, troubleshooting, and process improvements. Additionally, I was the only SME within North American branch of organization.For my key accomplishment in this role, I:- Played key role in development of new product offering, liaising with globally dispersed teams to create rocking motion bioreactor (RM Tx) for autologous cell therapy applications. Contributed technical expertise throughout development process, leading to successful development of product to target multi-billion-dollar market. As part of my key responsibilities, I:- Consulted with customers from start-ups to large pharmaceutical companies and to fully understand needs and determine optimal solutions based on available technologies. - Provided technical hands-on training to customers as part of post sales support at customer site or during equipment evaluations. - Partnered closely with R&D teams in Germany and Switzerland to develop newest product in portfolio for cell therapy applications. Lend technical expertise on simulated product processes to ensure product specifications meet client requirements. - Created marketing strategy for upstream product portfolio based on quality by design application to process development, process validation, and manufacturing.- Prepared presentations to demonstrate marketing positioning for products, outlining detailed analysis of technical aspects for competitor products compared against Sartorius offerings to highlight advantages. - Liaised with customers to understand operational processes and associated business requirements to ensure product offering aligns with goals.

I designed and implemented processes, leveraging in-depth knowledge of experiment design to contribute to development of autologous cell therapy applications using human primary T-cells. I also led development of strategy for process characterization and process control as well as execution of experiments for process characterization. Among my selected accomplishments, I:- Drafted process control strategy for leading clinical drug product. - Created a simplified step by step guide for experimental design and results analysis for use in process development. The document led to considerable time and cost saving for scientists and engineers in process development group.As part of my key responsibilities, I:- Designed experiments for process development and characterization to increase process and product development capacity, collaborating with scientists to understand desired outcomes for experiments and risk assessment.- Performed detailed modeling and statistical analysis of data to draw conclusions, synthesize results into presentations for stakeholders, and offer recommendations on next actions. Outlined critical process parameters impacting product quality and drafted document including variables and appropriate operating ranges. - Lead technical process characterization of leading drug product. Developed strategies for process characterization and documented process characterization master plan, mapping processes for each unit operation outlining all relevant input and output variables. - Drafted protocols for process monitoring by utilizing univariate and multivariate statistical methods, creating easy-to-use JMP interface to download manufacturing data from the server and allow user access to various charting options to evaluate historical status of various process variables. - Adhered to project deliverables and timelines, completing product development tasks under tight deadlines to meet demands of a fast-paced CAR-T company.

I provided Statistical Process Control (SPC) for multiple manufacturing areas through routine process monitoring as well as in-depth data analysis for various investigations in process or drug product quality-related issues. Additionally, I recommended change control, corrective, and preventive measures. Among my selected accomplishments, I:- Implemented data collection tool for manufacturing areas 2 years ahead of established schedule, completing project expected to take 2.5 years within 6 months. - Created an online process data monitoring dashboard with interactive charts, batch genealogy, automated alerts if control limits were exceeded, and side-by-side comparison of historical yield results. The project was endorsed for adaptation at other Sanofi Pasteur sites in the USA and FranceAs part of my key responsibilities, I:- Utilized JMP and SIMCA to conduct univariate and multivariate data analysis, evaluating various types of data and completing statistical analysis to perform root cause analysis of process issues and associated factors. - Established and maintained relationships with long-time personnel to ensure timely entry of manufacturing data into new data management tool. Provided training sessions to complete tool adoption by all manufacturing personnel. - Initiated and conducted investigations into issues with product quality, acting as subject matter expert to lead data analysis and provide technical feedback to support continuous improvement in manufacturing processes.