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Bernardo Jose Guzman

Bernardo Jose Guzman

Consultant

Bernardo Guzman is an expert in Drug Product Development and Technology Transfer with 10 years in the Biotechnology industry, leading molecules from early development to commercialization. Bernardo specializes in Drug Product and Combination Product Process Validation, Formulation Development, Lyophilization, Aseptic Manufacturing, Root Cause Analysis, CMC Project Management, and CMC Regulatory Strategy.

 

Prior to consulting, Bernardo worked at AstraZeneca as a Senior Engineer, leading the Drug Product technology transfer of multiple biologics to Fill/Finish CMOs for clinical and commercial manufacturing. In collaboration with Fill/Finish CMOs, Bernardo managed project timelines, raw material sourcing, risk registers, and critical path items with senior stakeholders. In this role, he excelled in Process Characterization and Process Validation for liquid, lyophilized, and combination products, as well as served as the technical lead for container closure specifications, FMEAs, CAPAs, deviations, and investigations. Bernardo has authored the drug product and medical device sections of multiple IND, IMPD, and BLA regulatory documents.

 

Before leading drug product development, Bernardo led the formulation and dosage form design of early-stage biologics within the Formulation Sciences department. In addition, he performed GMP analytical testing of stability and lot release batches within the Analytical Quality & Logistics department of AstraZeneca.

 

Bernardo is PMP certified, and received his Bachelor’s and Master’s degree in Chemical and Biomolecular Engineering from Johns Hopkins University.

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