Deisy Corredor

SENIOR DIRECTOR, CMC - PROCESS DEVELOPMENT, SERNIOR PROJECT MANAGER

Results-driven bio-process CMC Leader with extensive experience in CMC bio-process development.  Demonstrated success is leading group efforts in highly matrixed teams and supporting CMC activities for early and late-stage clinical programs.  Expert in Cell Culture and DSP purification process development, optimization, scale-up/down, controllability, and technology transfer.  Clear communicator, expert in alliance/ vendor/ CRO/ CMO Management, facilitating interaction between cross functional R&D, Regulatory, Quality, and Manufacturing/ Engineering.

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Deisy earned her PhD in biological engineering from KSU, and has over a decade of pharmaceutical industry experience.  She has emerged as a distinguished leader in bio-process development and technology transfer from R&D to CMC.  She recently worked leading cross-functional microbial platform teams within Sanofi-Aventis as a US Head of Bio-process Engineering.  Her journey began when she assumed the role of Director of Late Stage Process Development at Synthorx Pharmaceuticals, spearheading the initial technology transfer and scale-up of leading molecules to external CDMOs.  Following the acquisition of Synthorx by Sanofi-Aventis, her contributions led to her promotion to Senior Director of Early and Late-Stage CMC Development.  In this capacity, she guided the Protein Science team in the development of innovative biological processes while providing crucial support to Sanofi team during the internalization of projects and contributing as author and reviewer of two successful IND and IMPD submissions of therapeutic proteins crucial for I/O treatments.

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Prior to her tenure, Deisy worked as a Product Leader in Development of IVDR genotyping devices at Illumina and as Upstream Group Leader of Pfenex Pharmaceuticals where she also co-authored a successful BLA submission of biosimilars.  Her specialization lies in CMC and process development, characterization, technology transfer, scale-up, and validation using Quality by Design tools within cGMP environments. Her comprehensive expertise extends to leading and overseeing interactions with external CMOs, ensuring strict compliance with ICH and FDA requirements.

In summary, Deisy is a successful leader in the field of CMC - bio-pharmaceuticals, known for her outstanding leadership, technical expertise, and remarkable ability to bridge the gap between research and commercialization.  Her passion for evaluating cutting-edge technologies, technology licensing, and technology transfer is the driving force behind her dedication to driving innovation and success in biopharma. 

• CMO Management

• Scale Up/ Down Models

• Technology Risk and Gap Identification

• Facility Fit

• Due Diligences

• IND, IMPD, BLA Filing/ Submission