Experience

ENEM NOSTRUM

• India
• Research Services
• 1 - 100 Employee

• Deputy General Manager

  • Apr 2021 - Present

• Sr. Manager

  • Jan 2018 - Apr 2021



Menovo Pharmaceuticals

• Ningbo, Zhejiang, China

• Sr. Manager (R and D Formulation)

  • Oct 2014 - Aug 2016

  • Product Development: Led end-to-end development for ANDA projects in line with global generic development approach. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets and Capsules) to regulated markets of U.S.A as per QbD approach. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product… Show more • Product Development: Led end-to-end development for ANDA projects in line with global generic development approach. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets and Capsules) to regulated markets of U.S.A as per QbD approach. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product stability, process scale up & optimization, formulation optimization, technology transfer documentation, exhibit/ submission batch manufacturing, data compilation, etc. o Designing of patent non-infringing strategies for the product development. o Stabilizing the formulation & establishing in vivo – in vitro co-relation by dissolution mapping to insure bio-equivalency. o Applying DoE at various stages of development and Technology Transfer. o Documentation – Preparation of MFR’s, Stability and Sampling protocols, Process Evaluation batch documents, In-process & Finished product specifications, Raw material specifications, Product development report in QbD format. o Achieving positive results by motivating and guiding the team in taking the projects from the start till the end. • Project Management: Led end to end project Management for all ANDA projects, ensuring on-time project progressions, product registrations & launch plans. • Selection of Good CRO for In-Licensing the projects, costing, agreement finalization setting the timeline for project etc monitoring each and every activity till completion of scope of work or project. • Involved in API source finalization based upon the requirement and commercial point of view. • Selection of required Clinical CRO for BE studies, its agreement, costing and coordination till studies. • Coordination with manufacturing site from slot finalization till ANDA documentation. • Support regulatory team for ANDA submission. Show less • Product Development: Led end-to-end development for ANDA projects in line with global generic development approach. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets and Capsules) to regulated markets of U.S.A as per QbD approach. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product… Show more • Product Development: Led end-to-end development for ANDA projects in line with global generic development approach. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets and Capsules) to regulated markets of U.S.A as per QbD approach. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product stability, process scale up & optimization, formulation optimization, technology transfer documentation, exhibit/ submission batch manufacturing, data compilation, etc. o Designing of patent non-infringing strategies for the product development. o Stabilizing the formulation & establishing in vivo – in vitro co-relation by dissolution mapping to insure bio-equivalency. o Applying DoE at various stages of development and Technology Transfer. o Documentation – Preparation of MFR’s, Stability and Sampling protocols, Process Evaluation batch documents, In-process & Finished product specifications, Raw material specifications, Product development report in QbD format. o Achieving positive results by motivating and guiding the team in taking the projects from the start till the end. • Project Management: Led end to end project Management for all ANDA projects, ensuring on-time project progressions, product registrations & launch plans. • Selection of Good CRO for In-Licensing the projects, costing, agreement finalization setting the timeline for project etc monitoring each and every activity till completion of scope of work or project. • Involved in API source finalization based upon the requirement and commercial point of view. • Selection of required Clinical CRO for BE studies, its agreement, costing and coordination till studies. • Coordination with manufacturing site from slot finalization till ANDA documentation. • Support regulatory team for ANDA submission. Show less



Getz Pharma Research

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Research Scientist

  • Sep 2010 - Sep 2014

  o Leading a team of 6 scientists for developing the products for Regulated market as per client scope of work. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets, Capsules and Suspensions) to regulated markets of U.S.A & Europe. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product stability… Show more o Leading a team of 6 scientists for developing the products for Regulated market as per client scope of work. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets, Capsules and Suspensions) to regulated markets of U.S.A & Europe. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product stability, process scale up & optimization, formulation optimization, technology transfer documentation, exhibit/ submission batch manufacturing, data compilation, etc. o Compilation, analysis & conclusion of analytical data of formulations such as tablets, capsules. o Designing of patent non-infringing strategies for the product development. o Coordinate with other departments & provide technical support to Manufacturing, Quality assurance, Regulatory affairs. o Stabilizing the formulation & establishing in vivo – in vitro co-relation by dissolution mapping to insure bio-equivalency. o Applying QbD at various stages of development and Technology Transfer. o Documentation – Preparation of MFR’s, Stability and Sampling protocols, Process Evaluation batch documents, In-process & Finished product specifications, Raw material specifications, Product development report. o Execution of Validation batches for USA & Europe market. o Addressing FDA Deficiencies of post ANDA submission. o Achieving positive results by motivating and guiding the team in taking the projects from the start till the end. Show less o Leading a team of 6 scientists for developing the products for Regulated market as per client scope of work. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets, Capsules and Suspensions) to regulated markets of U.S.A & Europe. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product stability… Show more o Leading a team of 6 scientists for developing the products for Regulated market as per client scope of work. o Responsibilities include Pharmaceutical development of Stable and Bio-Equivalent generic products (Tablets, Capsules and Suspensions) to regulated markets of U.S.A & Europe. o Design the entire product development cycle for Regulated Market (USA / Europe) comprising of Literature search, API characterization, Pre formulation, innovator product evaluation, product stability, process scale up & optimization, formulation optimization, technology transfer documentation, exhibit/ submission batch manufacturing, data compilation, etc. o Compilation, analysis & conclusion of analytical data of formulations such as tablets, capsules. o Designing of patent non-infringing strategies for the product development. o Coordinate with other departments & provide technical support to Manufacturing, Quality assurance, Regulatory affairs. o Stabilizing the formulation & establishing in vivo – in vitro co-relation by dissolution mapping to insure bio-equivalency. o Applying QbD at various stages of development and Technology Transfer. o Documentation – Preparation of MFR’s, Stability and Sampling protocols, Process Evaluation batch documents, In-process & Finished product specifications, Raw material specifications, Product development report. o Execution of Validation batches for USA & Europe market. o Addressing FDA Deficiencies of post ANDA submission. o Achieving positive results by motivating and guiding the team in taking the projects from the start till the end. Show less



Titan Laboratories Private Limited

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Research Officer

  • Aug 2008 - Aug 2010

  • Successful design, development and TT of 5 products for ROW/Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards developing… Show more • Successful design, development and TT of 5 products for ROW/Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards developing formulations to achieve the planned objectives. Show less • Successful design, development and TT of 5 products for ROW/Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards developing… Show more • Successful design, development and TT of 5 products for ROW/Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards developing formulations to achieve the planned objectives. Show less



Ipca Laboratories Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Associate

  • Jul 2007 - Aug 2008

  • Successful design and development of 5 products for Indian & Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards… Show more • Successful design and development of 5 products for Indian & Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards developing formulations to achieve the planned objectives. Show less • Successful design and development of 5 products for Indian & Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards… Show more • Successful design and development of 5 products for Indian & Europe markets. • Complete literature search including Patents, Journals, Internet and Encyclopedias. • Complete Documentation activities, preformulation studies, physico-chemical evaluation of Innovator Product and monitoring of stability studies of the projects under investigation. • At the laboratory bench level, in consultation with the group leader and product manager organize and execute experiments towards developing formulations to achieve the planned objectives. Show less