Dr. Shruti Bhat- Leader Pharmaceutical R&D.
Translates innovative concepts to profits- consistently !
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Dr. Shruti Bhat, PhD,MBA.
CAREER HISTORY:
Getz Pharma Research, Mumbai, India, Head Formulation R&D (Feb 2011 – Current)
Lead new drug product development programs, implement Quality-by-design (QbD) in the product development process / pipeline, Strategize and execute statistical experimental design & process optimization enabling dosage form development meeting specified quality criteria and timelines within optimal costs.
Advise scientific talent pool at GPR regarding patent non-infringing pathways for developing NDA, 505 B2 and generic dosage forms, as well as super generics and novel therapeutic platform delivery systems. Create intellectual property wealth for GPR and its clients.
Technical Advisor/ Consultant (Feb 2008 – Feb 2011)
Innoworks technologies Limited
Akela Pharma Limited
DRL Technologies Limited
Adroit Technologies Limited
Pharmascience Inc., Canada; Director, Pharmaceutical R&D (September 2007- March 2009)
Led a team of 90 people; Head of Innovative, OTC and Generic Formulation development labs, Clinical manufacturing- pilot plant, Process improvement & Validation, Technology transfer and Warehouse. Actively ran a portfolio of as many as 60-70 new products. Successfully faced 2 audits from Health Canada for the clinical batch manufacturing site.
Generated savings of over 5M $ CDN in product development expenses only in 1 year. Achieved an increase of 20% in pilot plant capacity utilization over the preceding years. Risk assessment techniques introduced by me during technology transfer and trouble- shooting practices achieved 65 % cost savings during scale-up for product commercialization.
Novartis Global services; Group Head (Global center Pharma) PHD- R&D. (June 2006- July2007).
Was actively involved with designing and setting up of 60 M (USD) new global lab at Hyderabad, India as per Novartis internal standards. This involved challenging discussions and negotiations with city personnel, local FDA, building architects, Swiss consultants, QA personnel, engineering teams, pharmaceutical machinery vendors, recruiters & staffing experts. Was responsible for designing and overseeing pharmaceutical development and analytical laboratories by implementing QbD and effectively managed personnel of multi-cultural work teams in India and Basel.
Unichem Ltd., Mumbai, India; General Manager, Pharma R&D (May 2003 – June 2006).
Led a team of 65 people; Head of Generic & NDDS Research and Project management. Successfully up-graded R&D facility to international standards in order to support product development for US, EU, Canada and others regulated markets.
Introduced Electronic laboratory notebooks, LIMS, ISO and lean 6 sigma and document management systems in R&D. Was responsible for getting 2 manufacturing sites approved by USFDA. Launched over 55 products in domestic and international markets.
Macleods Pharmaceuticals Ltd.,India; Manager R&D & Patents. (July ‘99 – April 2003).
Led a team of 90 people, Head, of Generic Research, Patents and Project management. Was actively involved in project strategizing and setting up a 15 M (USD) state of the art R&D facility. This included methodology and machinery set-up as well as building and motivating a team of 50 scientists across 7 positions and 3 grades. Was actively involved in preparation of dossiers and getting 43 products approved by Netherlands FDA for IDA.
Macleods was at 65th position of ORG ranking in 1999 (when I had taken over the R&D leadership). It had no internally developed products. Achievements out of my R&D- Patent strategic plan offset the scale to 95 % of products being developed internally taking the organization with a significant leap from 65th position in 1999 up to 27th position by year 2003.
Seale India Ltd. (RPG Life Sciences) ; Asst. Manager R&D; (Sep 1996 – Aug 1999).
Was actively involved in alternate manufacturing site approvals, technology transfers, liasoning with FDA, new product as well as analytical method development / validation (of injections, capsules and conventional tablets) and patent filings of bulk drugs, intermediates and formulations.
FDC Limited; Executive R&D Formulations; (June 1995 – Aug 1996).
Group leader of 2 scientists. Was responsible for development of eye drops, CR tablets, pellets, and flavored products such as ORS, dispersible, chewable and effervescent tablets etc.
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