Chief Operating Officer and Executive VP, R&D Kashiv Pharma, LLC
Co-founded and setup Kashiv Pharma, LLC in Jan 2011 and helped in recruiting executives, management and skilled scientists staff of Formulation, Analytics, Technical Services/ Operations and Quality. Purchased and qualified state of the art analytical labs, pre-formulation, pilot plant instruments and equipments. Kashiv is set-up to develop 505b2/ NDA projects, support third-party company research, manufacturing and technology platforms (in-licensing and out-licensing). Created systems for GLP and GMP SOPs, guidelines and policies for efficient functioning. Company is following FDA, OSHA, state and other federal regulations. A pharma industry veteran (~22 years) serving as a Lead Pharma R&D Executive, Business & Technical Expert with experience in generics and branded drug product development and market launch. Directed development and execution of 200+ new products leading to 150+ regulatory submissions and 100+ regulatory approvals/launches with several first-to-file opportunities. Strong leadership skills in mentoring and coaching scientists and chemists for “first to file” / high barrier products development, ANDA/ NDA filings, approval and launch in US market. R&D Lead Facilitator in establishing regulatory and quality systems for filing drug products in other global markets such as India, Canada and Europe. Experienced technical leader in establishing robust and efficient systems within R&D and corporate divisions. Systems include SOPs, policies, guidelines, technical records, enterprise resource planning software (SAP), quality databases, product development reports, and CMC documents. Synergized challenging product development (highly potent, difficult formulation, cytotoxic, unconventional dosage forms) in formulation, analytical and regulatory aspects. Always followed efficient work qualities in speed, accuracy, accountability, communication, team-work, and flexibility to meet current FDA and market/ business requirements.