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Summary

professional with 28 + years of rich diverse global experience in Formulation design, development and Manufacturing scale up of different dosage forms & delivery systems including liposomal products & Patents for the regulated markets. he is credited with the development & dossier submission of numerous ndas / andas. specialties: possess strong Formulation skills combined with sound business and scientific judgment in product positioning for commercial success in the international quality and regulatory arenas of the Pharmaceutical: Formulation / analytical / pkg. development, Technology transfer, Validation, stability studies & Patents activities of immediate/delayed / modified release products and injectables.

Experiences

Current Experience

  • Head - R&D and Regulatory file preparation.


    Since April 2005
    ·a new state of the art, custom design R&D of global repute(green field project) is created. -responsible for overall Formulation development and Clinical supplies manufacture for solid, liquid, semi-solid,injectables and medical nutritional products towards ind, anda and 505b(2) regulatory Applications. ·provided scientific Leadership & technical direction for Product Development projects and led multiple module groups of total 50+ scientific personnel. ·planed, organized, directed and monitored Product Development activities optimizing resources and expediting Clinical & registration accomplishment. managed department annual budget of $15+ million. ·responsible to introduce FDA’s 21st century initiatives (e.g. quality by design & pat). ·A new state of the art, custom design R&D of global repute(GREEN FIELD PROJECT) is created. -Responsible for overall formulation development and clinical supplies manufacture for solid, liquid, semi-solid,Injectables and medical nutritional products towards IND, ANDA and 505b(2) regulatory applications. ·Provided scientific leadership & technical direction for product development projects and led multiple module groups of total 50+ scientific personnel. ·Planed, organized, directed and monitored product development activities optimizing resources and expediting clinical & registration accomplishment. Managed department annual budget of $15+ million. ·Responsible to introduce FDA’s 21st Century initiatives (e.g. Quality by Design & PAT).

Past Experience

  • Dy. General Manager - R&D

    January 2004 --- March 2005
    ·developed and commercialized several controlled release / sustained release/delayed release products i.e. floating Drug Delivery system (mosappiride citrate sr & pentoprazole enteric coated seeds.

  • Dy. Manager - Formulation

    September 1994 --- January 2004
    heading Formulation unit especially liposomal Research group.

  • Manager - Pharma (R&D)

    May 1986 --- August 1994
    accountable for Formulation development & Technology transfer from parent company american cynamid company.

Knowledge

LinkedIn Assessment :
Technology transferFormulation developmentValidationDrug DeliveryANDAR&DRegulatory affairsFormulationPharmaceutical IndustryGMPQuality by DesignPharmaceuticsGeneric ProgrammingSOPRegulatory submissionsProduct developmentFDAHPLCV&VCleaning Validation

Education

  • Ph.D. in Pharmaceutics from Pune University,Pune,India in 2001
  • M.Pharm. in Pharmaceutics from Dr. H.S. Gour Universitty, Sagar, M.P. India in 1985
  • B.Pharm. in Pharmacy from Dr. H.S Gour University, Sagar,India in 1983

Area / Region

Riyadh Province, Saudi Arabia

Others

Driving License
  • No

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