Eric Yearley

Organizational Leadership & Team Development • Direct 13+ member analytical organization across cell-based potency, molecular biology, separations, and CMC analytical teams with 5 direct reports; full hiring, performance, and succession planning responsibility • Achieved dramatic throughput improvements: 10x (Fragment Analyzer), 7x (potency assays) via method optimization and automation Strategic Program Leadership • Spearheaded analytical control strategies for 3 clinical and 3 platform programs across biologics and mRNA-LNP vaccine platforms from pre-IND through Phase 3 • Implemented AGILE methodologies as Product Owner (Sprint planning, Scrums, Retrospectives) achieving 25% faster analytical delivery • Collaborated with cross-functional CMC teams to align analytical strategies with program milestones and regulatory requirements • Justified $1M+ annual CAPEX investments through strategic business cases aligned with portfolio priorities Quality Systems & Operational Excellence • Drove 98% deviation reduction (150/year → 2-3/year) through systematic process improvements and electronic data capture • Established GSP-compliant analytical methods ensuring ALCOA+ adherence while designing for seamless cGMP implementation at internal and CDMO/CRO QC functions • Led digital transformation: IDBS ELN implementation (20+ notebooks converted, 50% time savings, 100% adoption), automated instrument uploads, LIMS integration Regulatory Leadership • Authored/reviewed >30 method development, qualification, and validation reports, OOS investigations, and deviations • System owner/approver for 20+ validated analytical systems; executed IQ/OQ/PQ and maintained calibration/PM compliance • Provided SME input for analytical CMC sections in BLA (US) and MAA (EU) submissions, including FDA/EMA information request responses

Team Leadership & Development •Managed 11+ direct and indirect reports (Associate Scientist to Senior Scientist); responsible for objective setting, performance calibration, promotions, and compensation decisions •Built complete analytical development laboratory from ground up with 8+ platforms (ddPCR, qPCR, Capsid ELISA, LC-MS, SEC, CE, DLS, residuals) supporting AAV gene therapy characterization •Recruited and developed team of 8 scientists, establishing mentorship, training, and career development infrastructure CMC Leadership & Strategic Planning •Served as Associate Director representative on CMC leadership team, driving strategic alignment across quality, process, research, and regulatory functions •Led analytical strategy for novel pre-IND viral vector program; supported process team in achieving CMC initiation to IND-enabling toxicology material within 6 months—exceptional speed for gene therapy •Contributed analytical expertise to BBP-812 (Canavan disease) AAV program, which achieved RMAT, Orphan Drug, Rare Pediatric Disease, and Fast Track designations from FDA •Implemented Quality-by-Design framework defining CQAs, CPPs, and comparability strategy supporting FIH Process A to commercial Process B transition Regulatory & External Partnership Leadership •Authored analytical CMC sections for 2 INDs (US) and 1 IMPD (EU) regulatory submissions •Directed external partner operations across 3 concurrent CDMOs: contributing to SoWs, supported cGMP audits, reviewed QC release data, achieved ~95% first-pass method transfer success through comprehensive gap/risk assessments •Justified strategic CAPEX investments ($200K-$2M annually) including mass spectrometers ($500K-$1M) through ROI analysis •Established reference standard program for multi-site lot comparability •Directed OOS/OOT investigations and deviation root cause analyses using structured methodologies (5 Whys, fishbone, FMEA) supporting CAPA implementation and batch disposition

Established the analytical development laboratory at BridgeBio Gene Therapy in Raleigh, NC. Developed six analytical assays in less than 4 months to support both in-process and GMP testing of two AAV-based in-vivo gene therapy products. Maintained an average turnaround time of approximately two weeks for all internal analytical assay requests. • Led in the establishment of a new analytical laboratory which consisted of installing and commissioning of new equipment such as two Waters UPLCs (PDA, Fluorescence and CAD detectors), Sciex Capillary Electrophoresis and Capillary Isoelectric Focusing, Eppendorf Liquid Handler, ELISA station and Molecular Devices plate reader • Led in the transfer and qualification of three AAV-based analytical assays: capillary electrophoresis, size-exclusion chromatography and enzymatic potency assay • Implemented statistical analyses in JMP to develop control charts, assess comparability, determine outliers, create several Design of Experiments protocols, and assess acceptance criteria for five assays • My team developed ddPCR, Capsid ELISA, residual PEI, Capillary Electrophoresis, SEC, AUC, and in vitro enzymatic functional assays to support in-process and GMP testing • Part of a team which regularly conducted risk assessments and determined pQAs/cQAs in support of the QbD program • Statistically assessed results from AAV GMP DP, GMP DS, Non-GMP Reference Standard and forced degradation stability programs to determine/select DP formulation, reference standard stability, DS hold time, DP shelf life and in-use stability in actual clinical device. • Conducted mass and charge characterization studies of two AAV serotypes with a combination of mass spectrometry, ultracentrifuge, and charge-based methods • Managed three direct reports with doctoral and masters level experience

Co-led in the development of two assays to quantitate critical RNA species and metabolites for two individual programs at Precision Biosciences. Participated in the assessment and determination of cQAs and phase appropriate analytical methods to monitor these cQAs for one RNA-based gene therapy program. •Developed an assay to quantify the 5’ capping species of Precision Biosciences’ RNA samples with reverse phase ion pairing liquid chromatography and a ThermoFisher QExactive mass spectrometer •Quantified metabolites in serum samples with HILIC liquid chromatography and ThermoFisher QExactive mass spectrometer technology •Assisted in the determination of critical quality attributes (cQAs) and the appropriate analytical techniques to monitor these cQAs from the quality target product profile (QTPP) of a RNA-based gene therapy program at Precision Biosciences

Served as an expert scientific and matrix leader for the LC-MS, separations, biophysical and computational activities within the characterization and mass spectrometry group which is a part of the GSK Vaccines Analytical Development US division. Co-led in the laboratory move from the Research Triangle Park, NC to Rockville, MD. Developed over ten critical methods and techniques in both the protein-based and RNA-based vaccine programs at GSK Vaccines. Co-led in the initial design and development of the Good Laboratory Practice Program in the US Analytical R&D Department. • Elected as a Matrix Analytical Leader and single Point-of-Contact (POC) for the US analytical department in support of the Phase I GMP Batch Development Taskforce and the in-process studies/tech transfer of three cell culture processes across two European CMO facilities • Initiated a program to implement statistics calculated through JMP to eliminate redundant assays from the analytical panel that highly correlate with other analytical assays • Received two Silver Performance Awards for the completion of several critical and vital scientific programs • Wrote ten Good Laboratory Practice guidance documents on the standard protein compendial methods that aligned with ICH and FDA guidelines • Served as a Good Laboratory Practices Champion for the ARD department in FY 2016-2017 • Led as a POC to evaluate and probe new analytical methods for the assessment of GSK's protein- and RNA-based vaccines • Designed and implemented numerous biophysical characterization and computational methods for the early stage development of protein-and RNA-based vaccines • Sequenced and quantified GSK’s RNA samples with LC-MS Orbitrap mass spectrometer • Quantified E&L small molecules and peptides with the implementation of a GC/TSQ-MS and LC/TQ-MS

Created and maintained the protein liquid chromatography/mass spectrometry program at MacroGenics. Program manager for the computational/simulation capabilities that supported the pre-clinical team. Co-led in the setup and maintenance of SEC-MALS and DSC which are still implemented in the antibody engineering, purification, protein science, analytical, drug product and CMC activities at MacroGenics. Was responsible for the purchase of computational programs and instrumentation valued in excess of 1.5 million dollars to bolster the capabilities of the antibody engineering, protein science, protein purification, analytical, formulation and other CMC programs at MacroGenics from pre-clinical to late clinical stages • Experience with the development of reversed-phase, size exclusion and hydrophilic interaction liquid chromatography assays to separate and characterize MAbs, peptides, bispecifics, and fusion proteins (e.g. peptide maps, SEC, CE and charge variant species) • Implemented a number of liquid chromatography/mass spectrometry methods (intact and peptide mapping analyses) to solve numerous critical problems in the MacroGenics pipeline including: protein identification, drug conjugation, polysorbate concentration, S-S linkage confirmation, N/O-linked glycosylation, amino acid sequencing, de novo sequencing, analysis of drug product in different research preps, side product identification, modification analysis and protein folding issues • Designed biophysical characterization protocols and early stage formulation screens for an accurate assessment of drug leads in the pre-clinical and early clinical settings • Worked with several CROs to run LC-MS and biophysical assays for product understanding activities • Author of draft analytical methods, IND sections, CMC reports, regulatory filings, safety forms and company-wide memos • Managed two direct reports with undergraduate- and masters-level educational experience