Edwin Resol

Served as program GMP QA lead for bispecific antibody manufacturing (Phases 1–3), establishing QA strategies and ensuring phase-appropriate compliance through risk-based oversight of CDMO batch review, disposition, sterility assurance, and microbial deviations/CAPAs. Directed global CDMO GMP oversight for Zanidatamab, supported FDA Pre-Approval Inspections, and reviewed/approved BLA/MAA CMC sectio

Managed CDMO batch record review and batch disposition processes, contributing to commercial product approval while leading MQA oversight for ZW25 and ZW49 to support timely lot releases and supply maintenance. Developed commercial-readiness QA processes spanning CDMO oversight, deviation/CAPA, and change control.

Ensured product quality through batch production record review/approval and cGMP compliance, including conducting/approving manufacturing deviations and CAPAs. Led QA disposition of product intermediates/CoAs supporting ADC manufacturing (including conjugation steps) for Adcetris and supported CMC regulatory submissions for launch readiness.

Reviewed/approved batch records, SOPs, specifications, and CoAs, and led OOS investigations, deviations, and complaints to support GMP execution. Supported IND/MAA submissions and regulatory inspections through QA collaboration with CMC and project teams.

Managed internal GMP quality systems including document control, change control, deviation/CAPA, and annual product reviews, identifying trends and driving continuous improvement. Acted as QA liaison with CMC/project teams, supporting audits, training, IND/MAA submissions, and regulatory inspections.

Oversaw QA activities at CDMOs for rThrombin commercialization, ensuring GMP compliance and advising on quality issues. Strengthened QA processes for timely review/approval of deviations, change control, non-conformances, and CAPAs, and supported FDA/regulatory inspections as person-in-plant.

Managed QC activities for commercial and development Bio-Plex 2200 projects, approving QC/production documents, test methods, specifications, SOPs, and batch records. Dispositioned raw materials, bulks, intermediates, and final products, and established departmental training for stability and OOS procedures.

Managed release and stability testing for Aztreonam for Inhalation (sterile inhaled antibiotic + drug-device combination), coordinating CRO method development, protocols, specifications, and SOPs. Reviewed manufacturing documentation for GMP compliance to support clinical supply timelines in a virtual-development environment.

Served as primary QC contact for CRO-managed release/stability of finished product and API, developing GMP methodologies and specifications. Represented QC in CMC working group meetings and prepared IND sections supporting regulatory submissions.

Supervised QC for early-development biologics, developing test strategies/specifications for E. coli-derived fusion constructs, MCB, lysate, and bulk API. Led technology transfers to contract manufacturers, method qualifications, clinical-site setups, and CMC reporting for INDs/annual reports, managing release/retest programs under cGMP/cGLP.

Performed CDMO batch record reviews and supported timely lot releases for ZW25/ZW49 by reviewing/approving quality and regulatory documents. Authored SOPs and supported the audit program by performing audits and training personnel.

Earned a B.S. in Microbiology from Washington State University in 1987.

Earned a B.S. in Psychology from Washington State University in 1985.