* Drug Delivery and Formulation technologies for NCE enablement * Clinical and commercial product development * Tech-transfer and scale-up * Regulatory and CMC strategies

Commercial Manufacture and Packaging - Sterile liquids, Semisolids.

* Generics * ANDAs (Para III/IV). Pharma Technologies & Manufacturing Processes * Delayed Release, Modified / Sustained Release, Amorphous, Oral Solid Dosage Forms.

Research collaborations with European Synchrotron Radiation Facility (ESRF, France), National Synchrotron Light Source (NSLS, Brookhaven) and Keele University (Department of Physics, UK).

Leading Pharmaceutical Innovation & Product Development Department. Point accountability for building pharmaceutical therapeutic drug portfolio, clinical-to-commercial product development (CMC), regulatory dossier authoring and review, and tech-transfer to internal and external (CMO) sites. Leadership of recent successful ANDA / NDA registrations and commercial readiness / launches. Adept in CRO/CMO selection & management, material procurement and qualification, specification setting & justifications, validations, and CMC sections of regulatory submissions.

Accountability for Product Innovation & R&D Pipeline Portfolio: Product Ideation, matrixed assessments including R&D technical, legal, clinical, regulatory, strategic fit and business valuation; proof-of-principle and asset prioritization. Identify and progress CRO-CMO partnerships and due-diligence.

Championed development & integration of innovative Formulation & Process Technologies for Phase I-III Clinical & Commercial Drug Products. Developed Formulation Platforms (API properties definition, Excipient selection, and Process technology selection) for rapid progression of product development programs from clinical stage to Phase III & Commercial Manufacturing. Led late-stage development and tech-transfer of drug-enabling and bio-availability enhancement Oral Solid Dose (Tablets, Capsules) and Liquid formulation Platforms, including Hot-Melt Extrusion (HME), Solubilization, Nanoparticulate systems, Polymeric and conjugated systems, Drug Layering, Spray drying, Foam technology, Amorphous & Lyophilized systems, etc.

Led of QbD initiatives for late stage development programs. Developed NIR spectroscopy based PAT techniques and Platforms for Solid dose product manufacturing. Deep experience in Immediate and Extended Release products, and Pediatric dosage form strategies. Clinical (Phase I-III), Commercial Product Development and Technology Transfer.

NCE's (New Chemical Entities): Preformulation, Material Characterization and Formulation development. Subject matter expertise in high intensity / synchrotron XRD, thermal characterization, spectroscopy, polymorph screening, salt selection, amorphous materials, Gastroplus and Advanced molecular modeling (Accelrys) techniques.