Highlights:

Skills:Method Development, Method Validation, Pharmaceuticals, ANDA

Senior Manager, Analytical Development Institute 06/2019 - 04/2020
Novus Pharmaceuticals (ZMC Company), Shaoxing, Zhejiang China
Industry: Pharmaceuticals
• Leading a team of scientists responsible to develop analytical methods and to provide analytical support to formulation R&D for developing the injectable products for US, UK and Europe markets.
• Getting company ready for US, UK and Europe market. Handling regulatory queries, audits, provide technical inputs. • Responsible for reviewing and approving method validation protocols, analytical methods, technical reports, SOPs, method validation reports and other important reports/documents. • Responsible for preparing material budgets for entire project life and monthly status reports for individual projects. • Providing technical guidance to team members and supervising analytical activities including analytical support to formulation development, analytical method development and analytical method validation. • Training team members in all aspects and helping them to overcome the challenges in order to achieve company goals.--
Manager, Analytical Development Department 06/2017 - 11/2018
Rubicon Research Pvt. Ltd., Thane, Maharashtra India
Industry: Pharmaceuticals
• Leading a team of 15 scientists responsible to develop analytical methods and to provide analytical support to formulation R&D for developing the product for US and Europe markets.
• Handling regulatory queries, audits, client teleconferences to provide technical inputs and updates of their projects. • Responsible for reviewing and approving method validation protocols, analytical methods and other documents as well as writing technical reports, SOPs, method validation reports and other important reports/documents. • Responsible for preparing material budgets for entire project life and monthly status reports for individual projects. • Providing technical guidance to team members and supervising analytical activities including analytical support to formulation development, analytical method development and analytical method validation. • Training team members in all aspects and helping them to overcome the challenges in order to achieve company goals.--
Senior Manager, Analytical Development Laboratory 06/2016 - 05/2017
Mylan Laboratories Ltd., Ahmedabad, Gujarat India
Industry: Pharmaceuticals
• Leading a team of 15 scientists responsible for method validations for multi market submissions such as US, UK, Europe, WHO, etc.
• Handling regulatory queries and audits. • Responsible for reviewing and approving method validation protocols and reports and other documents as well as writing technical reports, SOPs and other important reports/documents. • Responsible for transferring validated methods to QC. • Providing technical guidance to team members and supervising analytical activities including analytical support to formulation development, analytical method development and analytical method validation. • Training team members in all aspects and helping them to overcome the challenges in order to achieve company goals. • Responsible for lab compliance and maintenance.--
Manager, Analytical Development Department 05/2014 - 06/2016
Rubicon Research Pvt. Ltd., Mumbai, Maharashtra India
Industry: Pharmaceuticals
• Leading a team of 10 scientists responsible to provide analytical support to formulation R&D for developing the product for US and Europe markets.
• Handling regulatory queries, audits, client teleconferences to provide technical inputs and updates of their projects. • Responsible for reviewing and approving method validation protocols, analytical methods and other documents as well as writing technical reports, SOPs, method validation reports and other important reports/documents. • Responsible for preparing material budgets for entire project life and monthly status reports for individual projects. • Responsible for transferring validated methods to QC. • Providing technical guidance to team members and supervising analytical activities including analytical support to formulation development, analytical method development and analytical method validation. • Training team members in all aspects and helping them to overcome the challenges in order to achieve company goals. • Responsible for lab compliance and maintenance.--
Group Leader, Senior Research Scientist, Analytical R&D 10/2005 - 04/2013
Amneal Pharmaceuticals LLC., Brookhaven, New York United States
Industry: Pharmaceuticals
• Leading a team of 5 scientists responsible to provide analytical support to formulation R & D for developing a bio equivalent product for ANDA.
• Training team members in all aspects and helping them to overcome the challenges in order to achieve company goals. • Providing technical guidance to team members and supervising analytical activities including analytical method development and analytical method validation. • Handling and responding USFDA deficiencies. • Responsible for reviewing and approving validation protocols, analytical methods and other documents as well as writing SOPs, validation reports and other important reports/documents required in ANDA using ISI Writer (a tool helpful for eCTD). • Responsible for transferring validated methods to QC. • Responsible for lab compliance and maintenance. • Handling LC-MS/MS in critical projects for applications like low potency assays and impurity identification, etc.--

Mumbai University 05/1995 - 05/2000
Mumbai, Maharashtra, India
Degree: Bachelor's Degree
Major:Chemistry
Minor:Dyes & Intermediates
Bachelor of Chemistry

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