Basawaraj Chickmath Email & Phone Number

Accomplished Pharmaceutical R&D Scientist with extensive experience across Drug Product Development in a variety of dosage forms for small-molecules and complex drug molecules. Adept at optimizing in-depth understanding and execution of all phases of product development including pre-formulation, physicochemical characterization of formulation components, prototype formulation development, process optimization and scale-up, Tech Transfer and Validation, and commercialization of dosage forms including traditional and complex Oral Solid and Liquid Dosage forms, and Sterile Ophthalmic and Parenteral formulations. Practiced in complying with all regulatory standards for NDA (505(b)(i) and 505(b)(ii)) and ANDA submissions, and DEA (C-II-IV) requirements. Clear communicator, engaging collaborator, and apt leader, aligning internal and external partners, including Contract Development and Manufacturing Organization (CDMO) / Contract Research Organization (CRO) teams located across the US, Europe, New Zealand, and Asia. Areas of expertise:Chemistry, Manufacturing and Controls (CMC) and Strategic Leadership | Complex Drug Formulation Development CDMO Selection | Product Life Cycle Management | Bioavailability (BA) and Bioequivalence (BE) Clinical Strategy | Technical Due-Diligence | Pre-Clinical Development | Phase I and II Human Studies | Ophthalmic Formulations | Parenteral Formulations | Oral Solids and Liquids | Agile Project Management | Cross-Functional Collaboration Partnerships, Engagement, and Strategic Alliances | External Development Team Leadership: CMO and CDMO

Listed skills include Drug Delivery, Formulation, Pharmaceutics, Technology Transfer, and 13 others.