Accomplished pharmaceutical CMC professional with over 18 years of experience in pharmaceutical development. Skilled in complete CMC development activities from early to late-stage clinical development to commercial manufacturing of drug substance and drug product. Extensive experience in leading API process development, pre-formulation, and formulation development (solid, liquid oral and injectable formulation), clinical and commercial manufacturing of drug substance and drug products, CMC regulatory, analytical methods development, validation, transfer, and stability testing of drug substances and drug products. Thorough experience in methods development, validation and analysis of bio-analytical samples. Thorough experience in clinical and commercial supply chain management. Expert in regulatory filings and CMC regulatory strategy development. Author of multiple IND, IMPD, NDA, MAA sections for several filings with FDA, EMA and other global regulatory agencies. Led CMC activities that resulted in two successful NDA approvals, one MAA approval, several IND, and IMPD filings. A cross-functional team player with excellent organizational, communication and leadership skills. Comprehensive understanding of business processes for pharmaceutical manufacturing, program management, management of external CDMOs located internationally. Highly motivated, results oriented individual with demonstrated ability to foster great team teamwork.CORE COMPETENCIESCMC Operations - Medicinal Chemistry – Pharmaceutical Manufacturing - Synthesis Process Development- Pre-formulation and formulation development – Technology Transfer - CMC Regulatory affairs - IND, NDA, MAA, ANDA, IMPD regulatory submissions - Quality Assurance - Small Molecule API and Drug Product Manufacturing - Cross functional Team Leadership - CMC due diligence - Project Management - Supply Chain Management - Budget & Forecasting - CDMO management – cGMP - GLP, NR – ICH - FDA Guidelines - EU Guidelines – USP - NF - EP - BP & JP Pharmacopeias – Standard Operating Procedures – CAPA - Quality Control Protocols - Study Reports - Analytical Methods & SpecificationsTECHNICAL SKILLSSynthesis Process Development; Process Research; NMR; HPLC; GC; GC/MS; LC/MS/MS; ELISA; TGA; DSC; UV-VIS; Fluorescence & IR Spectrophotometer; Dissolution Apparatus; Chromatographic Instrument Control & Data Handling Software; Bioanalytical methods development/validation; ADME; Radiolabeling & Radioanalytical Instrumentation.