Harry A. Email and Phone Number

• Lead iPSC-derived NK cell process development

• Lead a team of scientists, responsible for the design, execution, and interpretation of experimental studies• Develop, optimize, and scale up a robust cell manufacturing process for autologous and allogeneic TCR-T drug products support IND enabling studies and GMP manufacturing• Act as primary SME for all internal and external process development and process instrumentation engineering activities including, but not limited to, target cell isolation platforms, automated cell washing, electroporation systems, controlled rate freezing systems, culture expansion, and cryopreservation systems• Author and review of technical documentation to support early-stage activities (development reports and supporting documentation for regulatory filings) as well as draft manufacturing documentation to support tech transfer• Collaborate closely with manufacturing to tech transfer the developed process to a GMP facility and act as SME during training / process shake-down runs

• Lead the design and implementation of a closed and automated clinical-scale manufacturing process for HSC-based autologous gene-edited drug product• Draft and review equipment standard operating procedures (SOPs), master batch records (MBRs), bill of materials (BOM), study/qualification protocols, internal memos and technical reports to enable GMP manufacturing and technology transfer• Author and review CMC sessions for regulatory submissions• Mentor and manage the day-to-day activities of three junior scientists• Communicate to functional line management and cross-functional teams regarding progress against technical objectives/milestones • Evaluate, optimize and troubleshoot systems and processes for cell isolation, washing, transfection, and freeze/thaw• Plan and execute manufacturing campaigns at CMO to generate materials for critical IND-enabling studies• Establish tracking and trending analyses of process development, pilot and cGMP production runs• Evaluate new technologies and drive scientific innovation in process development• Work independently and closely with cross functional colleagues in pre-clinical, analytical development and quality to advance program and corporate goals• Work with suppliers to ensure timely delivery of critical off- the-shelf and custom consumables and reagents• Source and implement new capital equipment to support process development and optimization

• Lead development and scale-up of SQZ process suitable for phase 1 clinical manufacturing of SQZ APCs for oncology• Design and execute process scale-up and process improvement activities, including cell isolation, SQZ, and cryo-preparation• Develop custom, completely closed, GMP-ready single-use disposable assemblies for manufacturing process• Support day-to-day activities at CMO to drive completion of tech transfer• Manage interactions with external vendors to ensure material readiness • Develop and implement analytical methods (e.g., cell counting, immunophenotyping) to support process development• Supervise and mentor direct reports

• Responsible for developing a robust SQZ process suitable for phase 1 clinical manufacturing• Evaluated cell processing unit operations for cGMP processing of cell therapy products• Conducted studies to understand critical processing parameters on product quality and stability• Designed and optimize assays for characterizing product identity, potency and purity• Planned and executed end-to-end in-house engineering runs• Authored internal documents (SOPs, experimental plans and technical reports) and contribute to federal grant applications• Mentored junior scientists and interns

• Explored the effect of particle shape and flexibility on hydrogel-based cell capture efficiency

• Developed a flow lithography process to print bio-inert (PEG-based) hydrogel colloids in a PDMS microfluidic device• Created non-spherical, compartmentalized microparticles using UV-crosslinkable oil-in-water nanoemulsions for controlled encapsulation and release of proteins, small hydrophobes, and nanoparticles• Formulated stable perfluorodecalin-in-water nanoemulsions• Fabricated multi-layer silicon wafers in a class 1000 cleanroom facility for molding microfluidic devices• Collaborated with other research groups on campus to characterize novel hydrogel biomaterials• Co-authored two successful multi-year research proposals (NIH, ICB) for new and continuation projects• Assisted 50+ students with fluid mechanics-related concepts and problems, as the TA for 10.301• Mentored two undergraduates, one graduate student on key laboratory techniques • Oversaw general laboratory safety and organized social activities for fellow lab members

• Collaborated with two other interns on two month-long assignments • Devised and implemented benchtop experiments to understand product characteristics in terms of measurable physical properties • Developed a pilot-scale operation to examine the effect of the various processing parameters (ingredient flowrate, order of addition, etc.) on product quality

• Collaborated with two other interns to identify potential investment opportunities• Estimated feasibility of promising options using economic and transport models (e.g., mass, energy)

• Assisted students with specific chemistry and calculus-related concepts and problems• Conducted classroom visits to promote Academic Development’s services• Received CRLA advanced tutor certification (Level 2) after completing more than 50 hours of mentoring work