Deepak Tiwari
Consultant Advisor Vice President Cmc Technical Operations & Supply Chain @Several Companies & Organizations
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WORK HISTORY
Consultant Advisor Vice President Cmc Technical Operations & Supply Chain @Several Companies & Organizations
NJ, US
Engaged by multiple venture-backed private/public/specialty pharmaceutical organizations to lead CMC strategy, technical operations, and late-stage development programs through critical inflection points including Phase execution, NDA readiness planning, portfolio reprioritization, and capital transitions.Serve as CMC subject matter expert providing strategic end-to-end CMC development, CDMO oversight for drug substance manufacturing, drug product formulation development, analytical strategy, process optimization, scale-up, and clinical / commercial supply chain management for small-molecule & large biologics program. Author/review CMC Module 3 sections for IND/NDA/BLA submissions and lead preparation for regulatory interactions.
EDUCATION
University of Delhi
BS, Pharmacy
St. John's University
PhD, Pharmaceutical Sciences
St. John's University
MS, Pharmaceutical Sciences
ABOUT DEEPAK TIWARI
Strategic pharmaceutical development executive with 25+ years of experience leading CMC, Technical Operations, and global supply chain strategy across biotech, specialty pharma, and large pharmaceutical organizations. Expertise spans small molecules, biologics, and drug–device combination products, supporting programs from preclinical development through Phase clinical trials, regulatory submission (IND/NDA/BLA), and commercial launch. Recognized for developing end-to-end CMC development strategies that integrate pharmaceutical development, manufacturing scale-up, regulatory readiness, and commercial supply planning. Extensive experience managing global CDMO networks, leading cross-functional development teams, and guiding organizations through critical value-inflection periods including Phase execution, NDA readiness, pipeline restructuring, and pre-commercial launch preparation. In addition to technical leadership, provide strategic support in CDMO business development and specialty pharma licensing, leveraging deep scientific expertise to highlight value proposition.Key Highlights• Leadership of CMC strategy across multiple Phase clinical development programs• Contributor to 20+ global regulatory submissions (IND, NDA, BLA, ANDA) and 7 commercial product launches• Oversight of global manufacturing and supply networks across multiple CDMOs• Author and reviewer of CMC regulatory filings with FDA and EMA interaction experience• Strategic advisor on licensing, manufacturing partnerships, and CDMO business development, contributing to >$25M in licensing, marketing, and CDMO development agreementsKnown for aligning scientific development, regulatory strategy, manufacturing execution, and supply chain readiness to accelerate development timelines and enable successful product launches.What I Do Best• Building end-to-end CMC development strategies from early development through commercialization • Leading CMC and technical operations organizations through Phase NDA/BLA submission, and launch preparation • Managing complex global CDMO manufacturing networks • Preparing organizations for regulatory approval and commercial supply readiness • Translating technical development strategy into operational and strategic business decisionsAlso serve as a strategic advisor to biotech and specialty pharmaceutical leadership teams on CMC strategy, manufacturing partnerships, and technical due diligence for licensing and investment decisions.
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