Michael W. Betts

Cellular therapy CAR-T manufacturing manager/specialist/consultant/engineer for an early-stage clinical biotech startup. Develops manufacturing processes by conducting experiments investigating numerous facets of rPOC; a next generation subcutaneous CAR-TaNK product for the treatment of B cell malignancies without preparative chemotherapy. Collaborates daily with Exuma research scientists and company leadership over all aspects of rPOC manufacturing in preparation for the initiation of stage 1 clinical trials. Converts research data into real world full scale GMP procedures, authors corresponding MBR/SOP and other relevant GDP documentation. Engineers manufacturing solutions to ensure streamlined, efficient, and compliant production parameters. Head manufacturing liaison with Moffitt Cancer Center Core Operations partners and responsible for tech transfer, IQ/OQ oversight, associate partner trainings, manufacturing supply chain management, and will function as the Exuma MSAT representative for future clinical trial manufacturing operations. In conjunction with company leadership, participates in development of future manufacturing strategy, scaling, and GMP facility buildout.

Manager of Manufacturing heavily involved in team, production, and culture building for facility startup operations at a major CAR-T production facility that will change the world. Responsibilities include hiring and team buildout, intensive training for associates of all skill levels along with associated mentorship and development. Design and execution of manufacturing corps culture, intended to set the standard for all that is to come. Performed user acceptance testing for electronic batch record CAR-T production recipes. SOP authorship and DCC, training, OJT authorship and validation, consultation in a variety of cell therapy production facets across departments. Interviewing, selection, hiring and onboarding of associates. Utilized Lean concepts to optimize production spaces, conducted and managed water runs in preparation for engineering runs in the near future. Drives RFT culture, empowers team drawing on years of cell therapy experience to develop and inspire future change-makers in the industry.

• Inaugural supervisor for JuMP Logistics Sanitization team, providing team creation and direct oversight while ensuring compliance and excellence in addition to fostering a vibrant culture and constructive work environment. • Drives right first time (RFT) culture and executes manufacturing unit operations by providing direct hiring, training, coaching/mentoring/development of personnel, and problem solving for a team of 17. • Head liaison between the Logistics Sanitization Team and associated operations across all departments including QA, QC, F/E, EHS, and site leadership. • Actively involved in the protection of patients and staff by directly coordinating responses to the detection of foreign microorganisms inside the cell processing facility and on associated equipment. • Appointed as a “Tier 1” designated SME for FDA Pre-License Inspection for “liso-cel”/JCAR017. • Interviewed over the course of several sessions by FDA inspectors during JCAR017 PLI in 2020, resulting in zero 483 Observations for area of expertise. • JCAR017/liso-cel FDA approval granted in February 2021.

• Manufactures cellular immunotherapy CAR-T treatments by T-cell selection, activation, transduction, cell expansion, and cryopreservation using aseptic techniques per SOP and batch records in accordance with current GDP and GMP practices • Operates equipment and executes processes safely and proficiently in ISO9, ISO8, ISO7 and ISO5 cleanroom environments • Builds collaborative relationships cross-functionally across departments and solves problems as they arise utilizing these relationships • Trains, qualifies and develops new team members to support core facility production activities, manufacturing logistics, open and closed unit operations, and facility sanitization • Maintains Cell Processing Facility (CPF) in constant state of compliance and inspection readiness related to equipment and area preventative maintenance • Works closely with cleanroom sanitization team to ensure that personnel are properly trained according to effective SOPs, and respond accordingly to the detection of foreign microorganisms in the CPF • Complete documentation including, but not limited to deviation initiation, paper and electronic manufacturing batch records, SOP authorship/ownership/editing, preventative and ad-hoc maintenance records, room / product line clearance and changeovers • Performs material movements and transfers in, out, and across the CPF