Pharmaceutical R&D Director
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Pharmaceutical, Biologics, Biosimilar, Nutrition, R&D Scientist with over 18 years of experience in drug product formulation within global regulatory and EHS compliances. Leading the laboratory with 40 scientists. Proficiency in the development pre formulation till commercial batch (lab scale to production, CMC), facilitate workshops and on floor events, lean and agile principles, methods, and tools.
Novel drug delivery systems (liposomes, nanoparticles, mAb), CMC, injectable, fill finish, prefilled syringes, nasal, oral solid, topical and liquid dosage forms. Developed complex drug product, medical device for the rare diseases, cancer, viral hepatitis and wounds.
Deep understanding of formulation within global regulatory compliance (FDA, TGA, NPRA, GMP EMA). Adept at fostering cross-functional collaboration, driving innovation through strategic planning and advanced R&D methodologies, and validation protocols. Committed to advancing pharmaceutical product development (with a focus on safety, efficacy, and quality, ensure alignment with organizational objectives and regulatory requirements.
This expertise enables me to bridge the gap between technical team and commercial goals. Nicotine products with PMTA submission.
First Indian scientist worked on COVID-19 with WHO, have developed Iron coated liposomes for cancer,
developed Collagen Type I based novel hemostat for US Nany, Carbon nanotubes for Retinitis pigmentosa. In house excipients to achieve targeted product profile (taste masking, SR and coating etc.)
In my management roles, I have honed my leadership skills, empowering teams to perform at their best and fostering culture of collaboration. As a forward-thinking leader, I am committed to staying abreast of emerging trends and technologies,
continuously seeking out new ways to drive business growth, create value for end user and stakeholders.