A formulation development and its process development specialist with 24 years of domain experience including regulatory audits exposure. A person who knows how to overcome the variability in product caused by MAN, METHOD, MATERIAL and MACHINE while transferring the technology from R&D lab scale to commercial scale.
Seeking a senior level position in the pharma industry, offering his technical and managerial skills in product development and/or transferring the technology from R&D level to commercial scale.Career Summary :
** 24 years of experience in pharmaceutical industry across renowned companies like Jubilant life science Ltd, Cadila Health care (Zydus Cadila), Cadila pharmaceuticals, Wings pharmaceuticals, Dabur (pharma), Hindustan Antibiotics Ltd.
** Working as Head-Technology transfer for last 3 years with Jubilant life science Ltd
Handled and lead functions like process development, planning and execution of scale up and Exhibit batches, documentation to support Drug regulatory affairs, Validation of first three commercial batches and represent R&D in regulatory audits.
** Have worked as Group head for 4 years in formulation development (includes tech. Transfer) in Cadila Healthcare Ltd and Cadila pharmaceutical Ltd .
Handled and lead the group of more than ten scientists for the development of formulations including technology transfer for Exhibit batches for regulated market like US, EU, Australia and South Afrika.
** Having worked as Technical Head for 2 years in Wings pharmaceutical, responsible for all technical work and development in the area of formulation development, regulatory affairs and quality assurance.
** Having worked as Principal Research Scientist for development of Formulation including Technology transfer in Dabur Research Foundation..
** Thorough practical Knowledge of Product development, technology transfer till commercial production on Production floor including process Validation.
** Practically solve the problems in pharmaceuticals arises due to variability in MAN, MACHINE, METHOD and MATERIAL.
** Thorough knowledge of Regulatory requirements with respect to Product development and its process development.
** Practically represent Tech. transfer and R&D in regulatory (USFDA, MHRA, ANVISA, PMDA) and Customer Audit.
** Managerial skill and Team development.Professional Experience :
Deputy General Manager- Head, Technology transfer (R&D centre Noida, Production facility Roorkee). (Jan 2008 till date)
** Responsible for complete technology transfer from R&D to Production Plant.
** Responsible for Coordination with various department for Procurement , planning and execution of scale up and filing batches.
** Responsible for process validation of first three commercial batches
** Responsible for timely providing documents to drug regulatory affairs for dossier filing.Significant Achievements:
** More than 60 products successfully transferred to Production floor. Sponsored links :
9 products taken to commercial production level.
** Successfully represent R&D in USFDA, MHRA and other regulatory and customer audit.
** Provide compliance documents to DRA at least for 36 products.
Sr. Manager ( Gr. Head in formulation development) in Cadila Health care Ltd. (Zydus Cadila),(Aug 2005 to Dec.2008).
** Responsible for timely developing bioequivalent product for US and EU market.
** Cost reduction of Existing Products for US and EU market.Significant Achievements:
** More than 18 bioequivalent products for US and Europe (include sustained release) successfully developed and filing batch taken for dossier submission.
** Represent R&D in USFDA and MHRA audit.
** Provide technical documents on product development against regulatory query.
Sr. Manager (Formulation development) in Cadila Pharmaceuticals ( June 2004 to July 2005).
** Responsible for timely developing bioequivalent products for US, Eastern Europe, Australia and South Africa market.
** More than 10 bioequivalent products developed for US, Eastern Europe, Australia and South Africa market.
** Represent R&D in TGA and MCA audit.
Head Technical in Wings pharmaceutical Ltd. (April 2002 to June 2004)
** Responsible for solving all technical problems related in existing range of products.
** Responsible for developing new products.
** Responsible for all activity related regulatory work including dossier preparation.Significant Achievements:
** The concept of Quality assurance first introduced in this organization. The formulation development and dossier preparation for product registration is first introduced and separate R&D lab developed in organization. Responsible for successfully managing WHO, GMP audit for COPP certification for products.
Principal Research Scientist in Dabur Research Foundation (April 1991 to March 2002)
** Responsible for developing new products for domestic market, South Africa and non regulated market.
** Transferring the technology to production floor and 3rd party manufacturing site.
** Responsible for solving all technical problems related in existing range of products.Significant Achievement:
** Wide spread experience of Product development and execution at production floor. Almost more than 80% Pharmaceutical products of total product range is handled by me and under my supervision.Early Assignments :
** Production Officer, Hindustan Antibiotics Ltd. Pune (April 1988 to March 1991). As shift incharge responsible for shift planning and production activities.
** Manufacturing Chemist, Albert David Ltd. (April 1987 to March 1988). As production supervisor in the manufacturing of Large Volume Parentrals..
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