Pedro Gautier

Director of Process Validation at Agilent Technologies

Speaker

Pedro J. Gautier is a seasoned pharmaceutical leader with over 25 years of experience in process validation, CMC strategy, and GMP manufacturing. Currently serving as Process Validation Director at Agilent Technologies, he leads validation programs supporting commercial oligonucleotide API manufacturing. Throughout his career, Pedro has guided cross-functional teams through Stage 1–3 validation, regulatory submissions, and PPQ execution across biologics and advanced therapeutics. He previously held leadership roles at Novavax, Boehringer Ingelheim, Thermo Fisher Scientific, and Amgen. Pedro is recognized for building high-performing teams, implementing risk-based validation strategies, and delivering inspection-ready, science-driven solutions that accelerate commercialization while maintaining rigorous quality and compliance standards