Formulation Development for US and Europe markets
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I have about 19 years of experience in Formulation Research and Development
It gives me an immense pleasure to introduce myself as a pharmaceutical Research and Development professional with about 19 years of research experience in the field of pharmaceuticals. Last ~19 years I have been associated with reputed pharmaceutical organizations in India like Hetero, Wockhardt Research Centre, IPC-I, Ferring Pharmaceuticals Limited, Glenmark Generics Limited, IPDO Dr. Reddy’s Labs and Bio-Arc, Alembic Limited in various leadership positions handling different product portfolios like Solid, Liquid and Lyophilisate products.
My over 5 years of association with IPC-I, Ferring Pharmaceuticals Pvt Limited gave me an immense insight into technicalities of pharmaceutical sector and developed me into qualified professional with sound knowledge of formulation and other facets of R&D of the sector. My association with Ferring Pharmaceuticals also provided me opportunity to develop my leadership abilities, which transformed me into a strong leader with the ability to lead professional of various skills and expertise. The team was credited to perform high value products with quality deliverable on time. During this period, I had worked on following products.
- Life cycle extension of Existing products (505(b) 2) and Lyophilisate platform development
Post Ferring Pharmaceuticals, I worked with Wockhardt Research Center in leadership role for a period of about 2 years handling the solid NDDS products (OROS formulations), NDA dosage forms and IR tablets.
I worked with Hetero labs Limted, Hyderabad in leadership role for a period of 3 years handling the solid oral dosage forms development for US/EU markets.
Currently I am working with Renata Limited (Ex-pfizer), Dhaka, Bangladesh from May 2020 to till date.
During last ~19 years of experience, I had worked in various dosage forms of generic products development of Oncho and non oncho ANDA Projects/505(b)2/ hybrid applications (IR/ER/OROS Tablets, Pellets, Capsules, Oral Lyophilisates, Suspensions and Solutions) for EU and US markets by QbD product development approach. Few products were extended to RoW markets.
I have experience in trouble shooting at various stages of product development (development, SU, EB and Pre-Validation and Validation).
I have experience in development of special dosage forms (Oral Lyophilisates), Complex generic products, hybrid applications and 505(b) 2 products for regulatory markets (EU and US markets).
I am confident that given the opportunity, I will significantly contribute and promote the vision and objectives of organization with new zeal.
I am looking forward to meet you in person and brief you about my professional expertise and accomplishments.
Please have a look on my profile below.
Master of Pharmacy - Pharmaceutics