Dr. Shruti Bhat- Leader Pharmaceutical R&D.
Shruti’s Leadership accomplishments in international R&D-
Leader-
Member of senior leadership team of dynamic, medium size – large corporates.
Provided strategic direction to start-ups and authored major business plans. Made informed go/ no go decisions. Brought R&D organization from its infancy to a $ 30 M market leader in 3 years.
Orchestrated site modernization targets, led turn around operations and major expansion plans.
Spearheaded quality-by-design (QbD) strategies that decreased new product development time by 35 %, reduced costs by 17 %, decreased machine down time and increased plant capacity leading to overall savings of 200 %.
Directed set-up of five state- of- the art R&D centres, planned AOP and CAPEX budgets, monitored spending and compliance/ audits.
Led technology assessments and due diligence related to licensing, partnership and acquisition initiatives.
Fostered high quality communications to convey sense of urgency, motivation and consistently achieved goals.
Created risk- assessment protocols for new product R&D portfolio and saved over $ 200,000 annually during technology transfer.
Created and monitored subordinate(s) growth plan and supported departmental succession planning.
Created focus groups or “Think- Tanks” and directed problem solving sessions to stimulate creative thinking and innovative approaches to successfully overcome issues related to research and product launch.
Led taskforce during technical audits by USFDA, EU-MHRA, Health Canada, WHO Geneva, Anvisa Brazil and DCI India.
Developed strategic alliances with academic and research institutes to access emerging technologies and pertinent tools.
Management-
Provided technical leadership and consultation for special initiatives and on-going R&D activities.
Improved productivity of R&D department by optimal use of resources and cost-control strategies. Overhauled in-effective work practises, established new standards, installed superior controls and built efficient cross-functional teams. Saved over $ 250,000 annually.
Oversaw project planning for product development portfolio. Consistently achieved 100 % delivery against agreed timelines.
Managed large diverse group comprising of 55 - 90 degreed scientists, engineers, shop floor technicians and office staff in a hierarchical, multi-cultural environment.
Managed R&D, process development and validation, ware house, technology transfer and clinical manufacturing departments. Less than 2 % employee turnover achieved annually.
Identified, hired and managed supplies, equipments and services for R&D and clinical- GMP manufacturing departments.
Supported planning and implementation of capital projects for operations group.
Supported champions for successful implementation of ISO and Six sigma.
Inventor-
Developed more than 900 new formulations comprising conventional generics and hi-Tech products currently being sold over 45 countries worldwide.
Research expertise includes development and process improvement of 18 different types of delivery presentations belonging to 35 therapeutic classes viz. Antibiotics, cardiovaculars, CNS, HIV, TB, malaria, diabetes, pain management, oncology, vitamins, neutraceuticals, probiotics etc.
Developed over 350 novel, mucosal and speciality products.
Specialist with development of pharmaceutical generics, bio-similars (follow-on generics), peptides & biotech based products, herbal, OTC and dietary supplements.
Developed break-through product “Forecox” anti-TB tablet introduced first in the world.
Achieved distinction of launching several products “First time” in Canada, US, Europe etc.
Holds 10 patents worldwide.
Familiar with PCT and national phase patent laws for Canada, US, EU, China and India.
Expertise with regulatory norms for 45 countries viz. US, Canada, S.Africa, Australia, Europe, Brazil and emerging markets, review and approval of CMC – development reports.
Authored 65 publications for leading pharma journals, innumerable online articles and SME to several blogs.
Member of senior leadership team of dynamic, medium size – large corporates.
Provided strategic direction to start-ups and authored major business plans. Made informed go/ no go decisions. Brought R&D organization from its infancy to a $ 30 M market leader in 3 years.
Orchestrated site modernization targets, led turn around operations and major expansion plans.
Spearheaded quality-by-design (QbD) strategies that decreased new product development time by 35 %, reduced costs by 17 %, decreased machine down time and increased plant capacity leading to overall savings of 200 %.
Directed set-up of five state- of- the art R&D centres, planned AOP and CAPEX budgets, monitored spending and compliance/ audits.
Led technology assessments and due diligence related to licensing, partnership and acquisition initiatives.
Fostered high quality communications to convey sense of urgency, motivation and consistently achieved goals.
Created risk- assessment protocols for new product R&D portfolio and saved over $ 200,000 annually during technology transfer.
Created and monitored subordinate(s) growth plan and supported departmental succession planning.
Created focus groups or “Think- Tanks” and directed problem solving sessions to stimulate creative thinking and innovative approaches to successfully overcome issues related to research and product launch.
Led taskforce during technical audits by USFDA, EU-MHRA, Health Canada, WHO Geneva, Anvisa Brazil and DCI India.
Developed strategic alliances with academic and research institutes to access emerging technologies and pertinent tools.
Management-
Provided technical leadership and consultation for special initiatives and on-going R&D activities.
Improved productivity of R&D department by optimal use of resources and cost-control strategies. Overhauled in-effective work practises, established new standards, installed superior controls and built efficient cross-functional teams. Saved over $ 250,000 annually.
Oversaw project planning for product development portfolio. Consistently achieved 100 % delivery against agreed timelines.
Managed large diverse group comprising of 55 - 90 degreed scientists, engineers, shop floor technicians and office staff in a hierarchical, multi-cultural environment.
Managed R&D, process development and validation, ware house, technology transfer and clinical manufacturing departments. Less than 2 % employee turnover achieved annually.
Identified, hired and managed supplies, equipments and services for R&D and clinical- GMP manufacturing departments.
Supported planning and implementation of capital projects for operations group.
Supported champions for successful implementation of ISO and Six sigma.
Inventor-
Developed more than 900 new formulations comprising conventional generics and hi-Tech products currently being sold over 45 countries worldwide.
Research expertise includes development and process improvement of 18 different types of delivery presentations belonging to 35 therapeutic classes viz. Antibiotics, cardiovaculars, CNS, HIV, TB, malaria, diabetes, pain management, oncology, vitamins, neutraceuticals, probiotics etc.
Developed over 350 novel, mucosal and speciality products.
Specialist with development of pharmaceutical generics, bio-similars (follow-on generics), peptides & biotech based products, herbal, OTC and dietary supplements.
Developed break-through product “Forecox” anti-TB tablet introduced first in the world.
Achieved distinction of launching several products “First time” in Canada, US, Europe etc.
Holds 10 patents worldwide.
Familiar with PCT and national phase patent laws for Canada, US, EU, China and India.
Expertise with regulatory norms for 45 countries viz. US, Canada, S.Africa, Australia, Europe, Brazil and emerging markets, review and approval of CMC – development reports.
Authored 65 publications for leading pharma journals, innumerable online articles and SME to several blogs.
