Angela Nunez, MBA.HMA, LATG, ILAM

Role Overview Serve as the Single Point of Study Control for high-complexity, non-clinical medical device biocompatibility programs (including Thrombogenicity and USP Class Testing) and acute and systemic toxicology within a global CRO environment. Separately direct and support non-clinical pharmacokinetics (PK) study designs for therapeutic pipelines. Key Responsibilities & Strategic Execution: • Direct study protocols under 21 CFR Part 58 (GLP), ISO 10993-1, and USP <87>/<88> standards to accelerate global regulatory and FDA submission pathways. • Lead the technical execution of complex GLP medical device projects, including In Vivo Thrombogenicity (Dog/Sheep), Acute & Systemic Toxicology, USP Class Testing, and Subcutaneous/Intramuscular Implantation. • Manage the full GLP study lifecycle from initial protocol assembly and animal model selection to the evaluation of raw data and issuance of final reports. • Partner directly with Sponsors and Quality Assurance (QA) to ensure study designs meet strict scientific goals, timelines, and regulatory expectations.

Role Overview Promoted from Scientist to Senior Manager to lead a multidisciplinary scientific team and direct internal and external CRO programs focused on advanced oncology cell therapies. Key Responsibilities & Strategic Execution: • Managed a team of scientific direct reports, leveraging Smartsheet to coordinate daily logistics and technical timeline execution for concurrent pharmacology and in vivo programs. • Directed assigned oncology pharmacology programs across internal and external CROs, tracking technical milestones, cross-functional budgets, and study timelines to secure regulatory-ready data. • Led the design and execution of efficacy and PK/PD studies for CAR-NK candidate selection (CAT-248, CAT-179 programs), evaluating data trends via GraphPad Prism for regulatory and IP filings. • Formulated primary human NK cells and led the in vitro isolation, culture expansion, and preparation of tumor cell lines for in vivo dosing protocols. • Developed subcutaneous xenograft models, integrating Living Image analysis, flow cytometry, and MSD biomarker analysis to monitor safety profiles.

Role Overview Served as a scientist directing external CRO pharmacology programs while spearheading in vivo studies to advance clinical-stage pipelines. Key Responsibilities & Strategic Execution: • Directed assigned external CRO pharmacology partnerships, leveraging Smartsheet to track data transfers, technical milestones, budgets, and timeline deliverables for clinical-stage agents. • Evaluated efficacy and safety profiles for the eTIL® cell therapy program, utilizing LIMS for cell tracking, sample logistics, and data consolidation to lead in vivo pharmacology studies that advanced pipeline candidates. • Orchestrated complex non-clinical study designs evaluating safety, tolerability, and Mechanism of Action (MoA) while analyzing preclinical trends via GraphPad Prism to ensure adherence to internal standards. • Led the in vitro preparation and culture of solid tumor cells, utilizing extracellular matrices like Matrigel to optimize formulation for implantation. • Executed advanced oncology models including syngeneic, CDX, PDX, and orthotopic implantation.

Role Overview Acted as Study Director and Lead, collaborating cross-functionally with Gene Editing and Oncology franchises to design, track, and execute assigned internal in vivo study programs. Key Responsibilities & Strategic Execution: • Collaborated with Gene Editing and Oncology franchises to design specialized internal in vivo studies, including CAR-T cell therapy and murine stem cell engraftment models. • Managed internal preclinical study tracking, data capture, and statistical trends leveraging Studylog and GraphPad Prism software platforms. • Established and prototyped new animal models internally, including pilot studies for model development and technical troubleshooting for advanced delivery routes. • Spearheaded technical training programs for junior staff to ensure data integrity and procedural consistency across the department.

Role Overview Promoted three times across an 11-year tenure to serve as Floor Lead and Study Lead, managing the execution of assigned internal in vivo safety and efficacy studies spanning multiple therapeutic units (Neuroscience, Rare Diseases, I&I, CVMED). Key Responsibilities & Strategic Execution: • Acted as Study Lead for complex internal studies, partnering with investigators (DSRD, PKPD) to develop and validate novel animal models involving radioactive compounds and high-precision tissue collection (CSF, thyroid). • Performed high-precision dosing (IV, IP, IM, SC, PO) and blood collection (RO, JV, CP, VC, SM, SB) across rodents, rabbits, and NHPs. • Executed full perioperative cycles for rodent surgical procedures, including Alzet osmotic pump implantations, aseptic technique, anesthesia, and comprehensive post-surgical monitoring. • Served as an active IACUC member; performed Post-Approval Monitoring (PAM) for internal in vivo studies to verify protocol adherence and ensure data integrity. • Maintained 100% audit readiness as Floor Lead for internal IACUC, USDA, and AAALAC inspections, while authoring critical facility compliance SOPs. • Trained and mentored junior scientific staff on operational standards and complex in vivo procedural execution to standardize practices and ensure global consistency.

• Performed room and animal health observations. • Practiced proper microisolator technique and maintained animal census. • Assisted in colony management: maintained breeding colonies, weaning and sexing. • Completed Principal Investigator requests for study support.