VP, MS&T

Vice President, Manufacturing Sciences & Technology (MS&T) Responsibilities Provide enterprise-level leadership for MS&T across the portfolio, aligning technical execution with strategic growth objectives and ensuring readiness for scale-up and increased manufacturing complexity. Lead MS&T strategy and operations for biologics and small molecule programs from late clinical development through regulatory submissions, licensure, and commercial launch. Oversee technical aspects of external manufacturing: process development, process validation, technology transfer, and routine technical support. Serve as primary MS&T lead for health authority interactions (FDA, EMA, and other global agencies), owning manufacturing strategies, control rationale, and lifecycle plans. Direct preparation, review, and defense of CMC regulatory submissions (INDs, BLAs, MAAs, briefing packages, Module 3) and ensure scientific rigor and regulatory defensibility. Partner cross-functionally with Process Development, Analytical Development, Quality, Regulatory Affairs, Commercial Operations, and Manufacturing & Supply for end-to-end technical and regulatory alignment. Design and implement operating models, governance, and talent strategies to scale MS&T for 2–5x growth (organizational design, recruitment, retention, leadership development). Establish risk management frameworks consistent with ICH Q8/Q9/Q10 and Quality by Design. Identify and implement best practices and technical innovations in process validation, technology transfer, and process optimization. Oversee data tracking and trending programs for process performance monitoring and compliance. Support preparation/review of technical and manufacturing documentation (protocols, process descriptions, batch records, SOPs, technical reports) with QA/QC. Qualifications Bachelor’s degree required in biochemical engineering, chemical engineering, pharmaceutical sciences, biotechnology, or related field; Master’s or PhD preferred. 15+ years biopharmaceutical industry experience, including 10+ years in biologics development and 5+ years in small molecule/solid oral dosage development. Demonstrated leadership of MS&T or Technical Development supporting original BLA submissions (not supplements only). Proven ownership of CMC regulatory strategy (IND/BLA/MAA authorship, defense, lifecycle management). Extensive experience in upstream, downstream, drug product development, process validation, technology transfer, and external manufacturing management. Documented experience scaling technical organizations through 2–5x growth. Deep understanding of biologics and small molecule manufacturing processes, control strategies, and regulatory requirements. Strong planning, management, critical thinking, problem-solving, and communication skills; ability to interface across organizational levels and external contract organizations. #J-18808-Ljbffr