Sunil Kamboj

Background

About Sunil Kamboj

With around eight+ years of hands-on-laboratory experience, I am a Research scientist proficient in Development of innovative medicines / differentiated formulation(s) with understanding from Proof of Concept (PoC) to Preclinical stages with intention of translating to New Drug Application (NDA)/ 505(b)(2) approval in Regulated markets, to address the unmet needs of patients. I am highly enthusiastic about my work and love to put my skills to use, ensuring the safety, quality, and efficacy of products. I work in close collaboration with cross functional teams – Developmental Quality Assurance / Regulatory Affairs/ Drug Metabolism and Pharmacokinetics/ Toxicology/Intellectual Property Management teams to drive the projects to subsequent levels and to ensure overall process completion. I have hands on experience in development of Solid Orals, Liquid orals and Nasal drug products. Have experience in leveraging the current drug products to different regulated markets with cost reduction. I have experience in preparation and review of R&D and plant documents. • Preformulation studies • Preclinical formulation development • Logistics / documentation support and R&D liaison for plant manufacturing activities and Execution of cGMP batches. • System & Equipment Standard Operating Procedures (SOP) – Training, Creation, Revision, etc. • Involved in generating proposals for new product introduction to build the product pipeline of the business unit. • Drug Delivery Systems Solid dispersions, Self emulsifying drug delivery systems, Lipid based oral formulations • Dosage forms Immediate release tablets, Delayed release tablets, Orally disintegrating tablets, Suspension • Pharmaceutical Processes Spray drying, Hot melt extrusion, Wurster process, Top spray granulation, Rapid mixture granulation Scale up • Quality by Design Expert knowledge of QbD principles