Aydin Ali Ozuer

• Led global TPM&M and CMC teams composed of -Technical Project Management -Digital Enterprise -Strategic Alliances -Manufacturing Science and Technology (MS&T) - Technical Operations and GMP Manufacturing • Led an integrated commercialization team composed of Global Manufacturing and Supply, Global Quality, Global Regulatory Affairs, Reg CMC, Supply Chain, Engineering, EHS, Safety, Cell Therapy Translational Engine • Directed design, construction and qualification of Cell Therapy GMP Manufacturing Facility (CTMF) in Boston

-Chief Project Manager to coordinate CMC source document collection for Pediatric Acute Lymphoblastic Leukemia (pALL) Biological License Application (BLA) for the first FDA approved commercial cell therapy product, KYMRIAH. -Leading the Technical Research & Development (TRD) team for assigned Cell & Gene Therapy development projects and Manufacturing Process Transfers to/from external partners/CMOs. -Managing the cross-functional studies within TRD and other line functions (e.g. Regulatory, Safety, Clinical, and Production). -Project Leader for Non-pivotal cGMP Multi-product Cell Processing Facility Design &Construction Project

Directed operations project management office activities that include • Technology Transfer o Commercial product process transfers among global manufacturing sites o New product process transfer from Process Development to Manufacturing • Collaborating with R&D and Operations to implement Process Analytical Technology (PAT) tools to design, analyze and control the manufacturing process o Identify Critical Quality Attributes (CQA) and measure Critical Process Parameters (CPP) o Apply design of experiments (DoE) and multivariate data analysis (MVDA) to implement Quality by design (QdB) principles o Inclusion of risk assessment tools (e.g. FMEA) o Establish correlation between quality attributes and clinical performance (safety & efficacy) o Understand of how variations in process parameters impact product quality • Data analytics/intelligence using multivariate data analysis using SIMCA (Umetrics) platform to o create & manage process database for continuous monitoring, trending and predictive analytics o collect and analyze process data to reduce variation and improve production yields, • Product launch and Change Management for strategic products

• Planned, managed and completed international product transfer projects in multidisciplinary matrix environment • Involved in multiple contract negotiation activities for acquisition and toll manufacturing • Provided risk & gap & capacity analysis, capital expenditures (CAPEX) & budget estimates for transfer activities • Prepared Technology Transfer Agreements, Technology Transfer Definition documents, Transfer SOPs • Implemented a new project management platform for effective management of technology transfer activities • Managed high priority process improvement projects increasing product yields 41% and lowering COGS 21%

•Served on a Due Diligence Team for an International Acquisition Projects •Identified and implemented lean product formulations •Led a project team to solve product/process problems of a top ten revenue generating brand •Managed several cross functional teams on new product and life cycle management projects •Supervised and successfully completed process improvement projects using 250-500L disposable Bioreactors • Worked on scale-down model studies for 300L, 3200 L and 5300L Stainless Steel Bioreactors -viral inactivation kinetics studies in 1000L Single Use Mixers (SUM) - successful master working seeds production under cGMP conditions •Coordinated manufacturing, filling, lyophilization campaigns for new product licensing serials •Worked on change control, cost of goods sold analysis (bill of materials& routings), disinfection, cleaning recovery, process validation protocols and quality standards •Designed and executed DoE based small-scale experiments

Gene Therapy Vector Production

•Managed activities such as release testing of bulk, in-process, final product and stability testing •Developed and validated a GLP assay system to analyze the quantity and quality of the vector stocks •Assisted to preparation of Quality and Production Plans for each project •Contributed to the HGTAL master validation plan •Recruited and trained HGTAL personnel

•Developed new production and purification strategies to scale-up viral vector and vaccine production •Communicated manufacturing related issues and manufacturing data to the stakeholders •Provided leadership for troubleshooting and resolving operational problems •Prepared SOPs and batch records to ensure compliance to cGMPs