• Working on CMC Formulation development & Technology Transfer to In-House/Third party sites of Solid/Liquid/Semi-solid/Herbal/OTC using QbD tools followed by Pre-formulation, Optimization Batches, BE/Clinical Studies, Budget Management, Costing, Regulatory approval.• Manufacturing Plant Setup and regulatory approval.• Business Project Management model with CMO/CRO around the globe depending on market. • Leading Project teams of highly motivated multicultural members from… Show more • Working on CMC Formulation development & Technology Transfer to In-House/Third party sites of Solid/Liquid/Semi-solid/Herbal/OTC using QbD tools followed by Pre-formulation, Optimization Batches, BE/Clinical Studies, Budget Management, Costing, Regulatory approval.• Manufacturing Plant Setup and regulatory approval.• Business Project Management model with CMO/CRO around the globe depending on market. • Leading Project teams of highly motivated multicultural members from Formulation, Analytical, Business Development, Stability Study Cell and Regulatory Affairs. Show less

1. Early Phase/Late stage Pre-Formulation and Formulation Process Development for Drug Product at lab scale (Non-GMP) to Pilot Scale (GMP) to Production Scale (GMP) considering Chemistry, Manufacturing and Control (CMC) activities of Oral Solids Liquids, Semi-solid and Injectable Dosage Forms along with Proper Documentation/Protocols/Reports2. Process Optimisation Batches and Technology Transfer Scale-up Batches.3. Responsible for In-Out Licensing technical parts, audits, material… Show more 1. Early Phase/Late stage Pre-Formulation and Formulation Process Development for Drug Product at lab scale (Non-GMP) to Pilot Scale (GMP) to Production Scale (GMP) considering Chemistry, Manufacturing and Control (CMC) activities of Oral Solids Liquids, Semi-solid and Injectable Dosage Forms along with Proper Documentation/Protocols/Reports2. Process Optimisation Batches and Technology Transfer Scale-up Batches.3. Responsible for In-Out Licensing technical parts, audits, material management and complete Project Management. 4. Techno-Commercial business plan for upcoming years.5. Third Party Contract Manufacturing (CMO) and Research (CRO) for Finished Products, Semi-finish Products, API consisting of Company identification, Drafting and negotiating Contracts, Service/Consultancy Agreement, Cost Analysis & Plant Audit. Show less

- Leading team of Scientists and Lab Technicians with at least 40 new projects for different tenders and markets. - Responsible for new formulation development of Solid and Injectable dosage forms for markets such as USA, Europe, Malaysia, Hong Kong, China, and other ASEAN Countries markets.- Identification and Risk Assessment of CPP, CQA, CMA from Formulation Development to Product commercialization and mitigate the same to achieve the Quality Targeted Product Profile… Show more - Leading team of Scientists and Lab Technicians with at least 40 new projects for different tenders and markets. - Responsible for new formulation development of Solid and Injectable dosage forms for markets such as USA, Europe, Malaysia, Hong Kong, China, and other ASEAN Countries markets.- Identification and Risk Assessment of CPP, CQA, CMA from Formulation Development to Product commercialization and mitigate the same to achieve the Quality Targeted Product Profile (QTPP).- Responsible for support on Existing Marketed Product in case of Regulatory or Production related problem and renovation of registration license and cost reduction approach using different source of API and Excipients.- Outsourcing of Products consisting of Finished Products, Semi-finish Products consisting of Re-sourcing, CDA, costing and Plant Audit. Show less

- To conduct Research and Evaluation projects on new products includes Generic Pharmaceutical Products, Over-The-Counter (OTC) products, Nutritional Health Supplements.- Responsible for a wide array of complex technical work needed to develop a high quality product for registration manufacturing, clinical studies and many more.- Responsible for formulation development of solid, liquid dosage forms for markets such as USA, UK, European countries, Hong Kong, China, and other… Show more - To conduct Research and Evaluation projects on new products includes Generic Pharmaceutical Products, Over-The-Counter (OTC) products, Nutritional Health Supplements.- Responsible for a wide array of complex technical work needed to develop a high quality product for registration manufacturing, clinical studies and many more.- Responsible for formulation development of solid, liquid dosage forms for markets such as USA, UK, European countries, Hong Kong, China, and other semi-regulatory markets.- API resourcing and auditing manufactures to obtain API of the pure quality.- To undertake laboratory trials for Solid and Liquid Pharmaceutical formulation and hand over formulation to Technology Transfer department for scale-up.- To participate “Exhibit batches” and responsible for successful completion of initial production batches along with stability study as per ICH guidelines.- Produce novel and value added formulations and processes and support patenting the new inventions- To manage product registration related documents such as Master Formula, Manufacturing Process, Critical Process Parameters, along with Pharmacokinetic Pharmacodynamic and toxicological data.- To assist in clinical study protocol preparation and monitor the study for assigned projects.- To prepare Product Development Report (PDR) as per ICH Q8- To assist in preparation of annual plan of department action and implement department budget. Show less

• Worked as a Formulation Development/Application Scientist for internal and external customer’s projects from Europe, USA, ANZ using various NDDS.• Technical Evaluation Team for M&A for Product life Cycle/Regulatory Evaluation & absorption into current product portfolios basket.• Handled NCE & New Excipients Entity for global projects for Stable Formulations and Patent drafting.

• Handled Para III, Para IV projects.• ANDA from Initial development, Successful BE Study, exhibit batch & successful technology transfer to various Production site.