• Led multi-site team and upstream and downstream PD efforts for viral vector platform development. Set up multiple external CDMO contracts worth $1.5 million, managed tech transfers and developed pilot-scale viral vector manufacturing processes across multiple programs (VIR-1388, VIR- 1778, VIR-1949) for Phase 1/2 clinical trials, resulting in IND submissions.• Successfully brought in novel fixed-bed and stir-tank bioreactor platforms and established process feasibility for future scale up to 1KL scale, including Process Analytical Technologies (PAT).• Improved impurity reduction by 100-fold through testing animal-free media, tangential flow filtration (TFF), and resin, membrane, and monolith-based ion-exchange chromatography approaches.• Collaborated on strategies for dosing, safety, DP stability, lyophilization, and drafting CQA & CPP. Improved manufacturability for Phase 2 and achieved projected ~10-fold decrease in Cost Per Unit (CPU), including assessment of critical raw materials, regulatory requirements, and risk.• Collaborated on data engineering project for a process run data repository, resulting in real-time dashboards enabling large data analytics, and successfully conducted team-wide business process mapping (BPM), data modelling (DM), and data preprocessing.• As part of rotation in Regulatory CMC group, successfully piloted AI/LLM project for streamlined IND submissions and co-authored structured data whitepaper as part of industry working group.• Hired, mentored, and guided team members, fostering a culture of collaboration, innovation, and continuous improvement within Tech Ops.

• Established and managed new Viral Vector PD group, fostering a collaborative and high-performing work environment and resulting in advancement to IND-enabling development stage gate ahead of time.• Developed robust transfection-based suspension viral vector production and purification process, resulting in submitted patent.• Successfully demonstrated process design, optimization, scalability and generated comprehensive data packages, ensuring alignment with business goals and regulatory requirements.• Completed collaborative build vs buy and COGs analyses, selecting CDMO for clinical stage manufacturing.• Established rigorous QC assays and procedures to ensure the purity, potency, and safety of viral vectors, meeting stringent regulatory standards.

• Established new Viral Vector Development group covering all process and analytical method development. Recruited and mentored a team of six professionals.• Concurrently managed viral development portfolio for three clinical programs:o Tabelecleucel Phase 2/3, EBV, now approved as Ebvallo™o ATA188 MS Phase 1/2, Adenoviral Vector (ADV)o ATA3219 Mesothelin CAR-T Phase 1, Retroviral Vector (RVV)• Performed RFP, CDMO selection, and contract negotiations, resulting in $3.3 million manufacturing agreement. Oversaw tech transfers and development work.• Conducted projects in process design, viral cell line development, process characterization (PC), and virus analytics, successfully supporting various allogeneic cell therapy initiatives.• Together with R&D group, drove early-stage targets towards IND milestones, effectively managed external collaborations with several CMO/CTO and enabled GMP manufacturing, assay development, and BLA preparation.• Led feasibility studies and development efforts for phase-appropriate strength and potency assays. Directed pivotal method qualification and co-validation efforts in conjunction with QC team, ensuring comprehensive documentation and change control assessments that enabled GMP readiness and PPQ/BLA.• Initiated and oversaw a comprehensive two-year CTO-partnered project resulting in development of fully qualified/validated ddPCR viral genome and ELISA impurity methods and meeting analytical needs for BLA.• Collaborating with consultants, devised and implemented characterization strategies for virus & cell line master/working banks and comparability strategies for GMP batches across process and site changes.

• Successfully established and led a new virology core function, including all aspects from laboratory space design, equipment selection, biosafety compliance, scientific leadership to core business management, and achieving >10-fold increased service income and hiring of 8 laboratory technicians/scientists.• Provided pivotal support for pre-clinical research studies, including disease models, gene therapy, vaccine challenge models and toxicity/biodistribution studies, leading to numerous collaborations, and helping to bring in $ millions in grant funding and co-authoring publications.• Developed comprehensive suite of multiple viral vector production and purification capabilities (eg ultracentrifugation DGUC/AUC), as evidenced by publication on AAV vector purification, and robust QC assays (qPCR, nqPCR, ELISA, virus titration bioassays).• Together with external partner, beta-teste and adopted novel multiplex antigen microarray methods that replaced standard ELISA techniques and enabled more effective routine antibody surveillance of 5 and 9-virus specific pathogen-free (SPF) macaque colonies.• Led production and rigorous quality control of virus antigen lysates for utilization in flow cytometry and ELISA assays, ensuring consistency and reliability in pre-clinical in vivo study outcomes.

Led Discovery and R&D team in a matrix setting. Oversaw and executed viral vector engineering, production and QC, lead candidate screening, and pre-clinical mouse immunogenicity studies. Developed new protocols and screening technologies. Presented findings at internal meetings and scientific conferences. Authored project protocols, budgets, manuscripts, and grants. Recruited, trained, and supervised laboratory technicians. Developed lead vaccine candidate selection approach based on innate immune screening method, engineered multiple novel adenoviral vector platforms, and successfully completed in vivo vaccine immunogenicity studies, resulting in publication. Successfully completed projects on time and reached additional milestones. Commended on significantly expanding the scope of research and introducing novel in-house immunoassay capabilities. Authored manuscripts and NIH grant submissions. Achieved co-inventorship on several patent applications.

• Development of autologous gene therapies for HIV/AIDS and genetic diseases. Planned, coordinated and executed several large-scale non-human primate studies involving myelo-/lymphoablation, gene transfer using lentiviral vectors, transplantation of gene-modified hematopoietic stem cells, and analysis of pharmacokinetics, gene marking and immune responses.• Investigated the biological role of the antiretroviral restriction factor TRIM5α in rhesus macaque tissues, and designed novel approaches to achieve efficient transduction with HIV-1- and SIV-derived lentiviral vectors.• Presented findings to team, laboratory, and departmental meetings, and national and international conferences.• Collaborated extensively with associated laboratories (often requiring significant travel).• Authored project protocols, two manuscripts, and supportive grant.• Trained and mentored graduate students.