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Summary

Expert in all R&D activity including formulation & analytical research aspects ...

Experiences

Current Experience

  • Reseach & Development section head (Officer)
    Since March 2016

Past Experience

  • Research & Development pharmacist ( Formulation & Analytical Research Dep.)
    April 2013 --- February 2016
    Formulation department : 1- Supervise the lab activities & ensure cGMP & EHS implementation. 2- Provide scientific, technical and operational support of drug products development. 3- Follow up the stock of API & Excipiens in the lab. 4- Prepare SOPs & ensure technical & quality aspects. 5- Prepare Master formula & Development report for registration file. 6- Literature survey including: Patent status – BCS – In-vivo, In-vitro assessment – API specification – Excipients specification –packaging suitability. 7- Pre-Formulation studies including: API characterization – compressibility testing – Crystalinity - polymorphism – API & Excipient compatibility testing using DSC , HPLC . 8- Formulate & develop the formulation process of solid dosage forms of pharmaceutical products. 9- Identify Ingredient dependent issues within formulation & processes. 10- Analyze, follow up and summarize the trials results. 11- Costing of the material quantities and man - machines hours for each trial. 12- Determine suitable primary & secondary packaging tools for new products. Production department (Pilot Stage ) 1- Prepare BMR & BPR for pilot Batches scale 2- Ensure Following up SOPs to fully implement the compliance to cGMP & EHS. 3- Set up the parameters of the machines in the production to facilitate an easy transfer of the pharmaceutical products from R&D lab. 4- Set up QbD protocol & follow up its implementation. 5- Provide direction, correction & motivate the operators to achieve the target quality at time schedule. 6- Manage the scientific, technical and operational trouble shootings occur. 7- Calculate Overall Equipment Effectiveness (OEE) involving calculate availability , performance & quality factors .

  • Research & Development Pharmacist
    September 2012 --- March 2013
    1- Analysis of R&D formulation samples of different forms Using different types of HPLC (Alliance-Breeze-shimadzu) , ACQUITY Uplc Waters, GC , UV spectroscopy apparatuses & Titration Methods. 2- Formulate & Develop the formulation process of different forms of pharmaceutical products . 3- Identify Ingredient dependent issues within formulation & processes . 4- Provide scientific, technical and operational support of drug product development. 5- Stability & Methodology : A) – Analysis of stability samples including their related substances . B) – Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products. C) – Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity. 6- Making Validation of the Analytical Methods . 7- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations. 8- Making Biowaiver Studies according to FDA Guidance . 9- Management of of Trouble shooting in different apparatuses with time planning schedule. 10- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP. 11- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.

  • Analyst & Formulator
    January 2011 --- August 2012
    1- Participate in the start up of the lab . 2- Analysis of QC Finished & Raw material of different forms Using different types of HPLC (Alliance-Breeze-shimadzu) , ACQUITY Uplc Waters, GC , UV spectroscopy apparatuses & Titration Methods. 3- Formulate & Develop the formulation process of different forms of pharmaceutical products . 4- Identify Ingredient dependent issues within formulation & processes . 5- Provide scientific, technical and operational support of drug product development. 6- Stability & Methodology : A) – Analysis of stability samples including their related substances . B) – Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products. C) – Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity. 7- Making Validation of the Analytical Methods . 8- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations. 9- Making Biowaiver Studies according to FDA Guidance . 10- Management of of Trouble shooting in different apparatuses with time planning schedule. 11- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP. 12- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.

  • Stability & Methodology pharmacist
    August 2009 --- December 2010
    1- Analysis of R&D Formulation & Stability samples of different forms Using different types of HPLC (Alliance-Breeze-shimadzu) , ACQUITY Uplc Waters, GC , UV spectroscopy apparatuses & Titration Methods. 2- Stability & Methodology : A) – Analysis of stability samples including their related substances . B) – Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products. C) – Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity. 3- Making Validation of the Analytical Methods . 4- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations. 5- Making Biowaiver Studies according to FDA Guidance . 6- Management of of Trouble shooting in different apparatuses with time planning schedule. 7- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP. 8- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.

Personality

Self Assessment :
OrientationTrustApproachability

Knowledge

LinkedIn Assessment :
HPLCFDAValidationTitrationColumn ChromatographyUV-VisTLCSpectrophotometrypH meterDissolutionUVLCChromatographyIRgas chromatographyAnalytical ChemistryQCDrug DiscoveryscienceGLPcGMPSOPQuality ControlCAPAFormulationQuality SystemUV/VisPharmaceutical IndustryRegulatory RequirementsPharmaceuticsQuality AuditingUSPDrug DevelopmentLaboratoryStandard Operating Procedure (SOP)SOPGMP

Skills and Expertise

Self Assessment :
Analyze data Analytical skills Build and manage the Trial Master File (TMF) Build the CMC development plan Create SOPs Develop protocols Control data

Education

  • Bachelor of pharmaceutical science in pharmacy from Faculty of pharmacy Zagazig University in 2009

Training and Certification

  • IRCA approved Iso 9001/2008 QMS Lead Auditor Certification

Languages

BrightOwl Assessment:
Self Assessment:
Arabic
Full Proficiency
English
Full Proficiency

Area / Region

Saudi Arabia

Others

Driving License
  • Yes