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Summary

Summary

 

  • Over 5+ years of Bio-pharma Industrial experience in Biologics, for its development and manufacturing.

 

  • Technology assessment, project planning, commissioning and qualification of manufacturing facilities, technology absorption, material preparation for preclinical and clinical study, and commercial manufacturing of biologics for regulated market.

 

Downstream process - protein purification, Technology Implementation and production, providing support to cGMP Production, & QA Departments.

Experiences

Current Experience

  • Production Incharge Sharjah - United Arab Emirates
    Since July 2015

    • Manufacture of Natural sweetener (Thaumatin) from Aril.
    • Working in RND scale up to production scale up and optimization of product and process flow.
    • Working in extraction, purification (MF, UF) and drying process.

Past Experience

  • Executive Bangalore, Karnataka, India
    April 2013 --- June 2015

    • Monoclonal antibody purification Process: Clarification by centrifuge & filtration, chromatography, UF/DF, viral filtration and formulation.
    • Cleaning: CIP and cleaning validation/verification activities.
    • Documentation: SOP/EOPs, BMRs, Batch reports, process analytical tool reviews, Change controls, Deviation handling, Validation protocols and equipment qualifications (DQ, FAT, SAT, IQ, OQ & PQ).
    • Scale up: TTD review, new document preparation, technical discussions and trouble shooting.

  • Junior Executive Bangalore, Karnataka, India
    November 2008 --- February 2012

    • Monoclonal antibody purification Process: Clarification by centrifuge & filtration, chromatography, UF/DF, viral filtration and formulation.
    • Cleaning: CIP and cleaning validation/verification activities.

Personality

Self Assessment :
AdaptabilitySelf-disciplineInterest in knowledgeFlexibilityEfficiencyCreative thinkingCoordinationCompetitivenessApproachabilityAttention to detailAnalytical thinkingSelf-confidence

Knowledge

Self Assessment :
Biopharmaceuticals R&DBiological Drug DevelopmentProcess improvementGood Manufacturing Practice (GMP)Pharmaceutical IndustryMicrosoft OfficeProblem-solving methods and troubleshooting

Skills and Expertise

Self Assessment :
Adjust processes and methods Develop protocolsAssist with procedures Create SOPsCalculate process efficiencyCalculate trial timelinesCapture data on source documentsDocument data reporting systemsEvaluate protocolsManufacture of GMP batchesRespond to audit findings

Education

  • Master in Production from MKU University in 2015
  • Bachelor in Biotechnology from A C College of technology, Anna University in 2007

Training and Certification

  • cGMP in 2015 Training
  • Safety in 2015 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Product Manager Project Assistant Project Coordinator Quality manager
  • Locations I am interested in:
    United Arab Emirates
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Sharjah - United Arab Emirates

Others

Driving License
  • No