Dhavall Shah
Associate Director- Gene Therapy Dp Msat Manufacturing @Sarepta Therapeutics
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WORK HISTORY
Associate Director- Gene Therapy Dp Msat Manufacturing @Sarepta Therapeutics
Led the execution and strategic development of external manufacturing for gene therapy drug products across multiple global CMOs, ensuring robust supply chain and strategic alignment.Drove key initiatives in CDMO relationship management and performance oversight, proactively resolving challenges and ensuring contract adherence as an individual contributor.Directed critical tech transfer, scale-up, and validation initiatives for DP manufacturing processes, successfully transitioning products from clinical to commercial readiness.Championed the definition and implementation of KPIs and governance models for CDMO performance, significantly enhancing accountability and compliance with global regulatory standards (FDA, EMA).Strategically supported global submissions (BLA, EMA, Swiss Medica, PMDA, ANVISA), directly contributing to timely approvals and global market entry.Initiated and drove cost-efficiency projects (e.g, BOM rationalization, filter upgrades), achieving 20–30% cost reduction and optimizing vendor utilization.Established and leveraged robust data dashboards for real-time tracking of yield, deviations, and manufacturing KPIs, providing critical portfolio-wide insights.
EDUCATION
L.M. College Of Pharmacy
B.Pharm
Long Island University
Doctor of Philosophy (PhD), Pharmaceutical science
Long Island University
M.S, Industrial and Physical Pharmacy
ABOUT DHAVALL SHAH
Accomplished pharmaceutical executive with 10+ years of progressive leadership in technical operations, external manufacturing, and MS & T (Manufacturing Science & Technology) across sterile injectables, complex biologics, and drug-device combination products. Recognized for building and leading high-performing teams, driving operational excellence, and delivering robust, phase-appropriate solutions from preclinical development through commercial launch.Expert in developing and executing external manufacturing strategies, optimizing CDMO partnerships, and ensuring seamless technology transfer and process validation. Adept at navigating global regulatory landscapes (FDA, EMA, ANVISA), supporting successful IND, NDA, ANDA, and BLA submissions, and implementing data-driven approaches to risk mitigation and continuous improvement.Core strengths include cross-functional leadership, CMC regulatory strategy, KPI development, and operational governance. Passionate about leveraging innovation and strategic planning to accelerate product development, enhance supply chain resilience, and ensure quality and compliance in a dynamic, global environment.
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