Vinod Patil

About Vinod Patil

Ph.D-trained drug product leader with 10+ years of industry experience driving end-to-end development of solid oral oncology and specialty pharmaceutical products from concept through global commercialization.I provide strategic CMC leadership aligning formulation development, manufacturing scale-up, regulatory strategy, commercial launch execution and product lifecycle management. I have directed CMC development and regulatory submissions culminating in FDA/EMA approvals and global launch readiness.Core Expertise:• CMC Strategy & Authoring DP sections for Regulatory Submissions (IND/IMPD/CTA/NDA/MAA, etc.)• Commercial Launch & Lifecycle Management• Oral Solid Dosage (Immediate & Modified Release)• Formulation development, Technology Transfer, Process Scale-Up & Process Validation• Global CDMO Leadership & Technical Governance• Cross-Functional & Matrix Leadership• Risk Mitigation & Program AccelerationGlobal Experience:Extensive collaboration with development and manufacturing global partners across US, Canada, Europe, and China, leading cross-cultural, multi-site programs to successful regulatory and commercial outcomes.Leadership:People leader managing and mentoring high-performing scientific teams while advancing multiple complex programs in fast-paced, global environments.Published author in peer-reviewed international journals, contributing to advancements in drug delivery and formulation science.

Experience

1. Associate Director, Cmc Pharmaceutical Development

   SpringWorks Therapeutics

   Jan 2025 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Note: SpringWorks Therapeutics was acquired by Merck KGaA, Darmstadt, Germany in July 2025.

Education

• Institute Of Chemical Technology

  B.S., Chemical Engineering

• University of Kentucky

  Doctor of Philosophy (Ph.D.), Chemical Engineering

Skills

• Polymer Characterization
• Drug Delivery
• Dynamic Mechanical Analysis (Dma)
• Materials Science
• Broadband Dielectric Spectroscopy (Bds)
• Differential Scanning Calorimetry
• Hplc
• Gpc
• Uv/Vis
• Tableting
• Tga
• Microsoft Office
• Matlab
• Python
• Vba
• Aspen Plus
• Ftir
• Biomaterials
• Process Engineering
• Product Development
• Polymers
• Polymer Composites
• Polymer Chemistry
• Chemical Engineering
• Characterization
• Spectroscopy
• Nmr
• R&D
• Data Analysis
• Formulation
• Solid Oral Dosage Forms
• Design of Experiments