Senior Director, CMC Technical Lead

Role: Senior Director, CMC Technical Lead for AAV gene therapy, overseeing the technical integrity and regulatory narrative of Module 3 in BLA submissions. Responsibilities: own and connect the integrated control strategy across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance; author and integrate the technical content for regulatory filings; lead the comparability strategy and risk assessments; chair the CMC Technical Review Board; support BLA authoring and agency interactions; ensure process understanding transitions to commercial manufacturing; serve as a technical authority in cross-functional decisions without direct reports. Requirements: PhD in a relevant scientific or engineering discipline; 10+ years in biologics or advanced therapies CMC, with experience in AAV manufacturing, analytical characterization, and regulatory submissions; proven expertise in control strategies, regulatory inspections, and process validation. HighValue: biologics, gene therapy (AAV), CMC development, BLA Module 3, regulatory strategy, process characterization, PPQ, commercial launch. WorkSetup: hybrid model with remote work and site visits (<15%) to Houston, TX; fast-paced environment.