Jagdish Shinde Email and Phone Number
Jagdish Shinde work email
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Jagdish Shinde personal email
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Bio process technologist having hands on various unit operation in downstream process.Solid liquid separation Using continuous centrifugation and Depth filtration. Optimization of Sizing of Depth Filter and Concentration step by TFF scale up of TFF , Evaluation of cleaning efficiency of TFF. Virus filtration Purification step such as preparative Chromatography of different principle, Scale up of chromatography, column packing and column Evaluation .Specialty in cGMP Operation Quality management system such asData Integrity 21 CFR part 11sterile area (clean room ) its Qualification and maintenanceEquipment, Utility and Facility qualification and commissioning HVAC QualificationChange controlDeviationCAPARoot cause Investigation ( Tool 5 Why and Fishbone)Cleaning Validation, Process Validation and Product change overDocumentation TTDBMRSOPVMPMFRDifferent Validation Protocol Guideline ICHSchedule MWHOPIC/SEU GMPISO 14644Technical . GMP and Documentation knowledge for Biosimilar.Major role in Manufacturing and Engneering compliance
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ManagerCurateq Biologics Oct 2023 - PresentEnsure all manufacturing processes (DS and DP) adhere to regulatory guidelines (FDA, EMA,ICH) standards.Review production records to identify deviations or non-compliance.Conduct audits and internal reviews to ensure processes meet quality control standards.Collaborate with other departments to ensure product quality.Report on compliance issues and help develop corrective actions.Vendor Qualification
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ManagerCurateq Biologics Apr 2021 - Sep 2023Hyderabad, Telangana, IndiaMonoclonal Antibodies (mAbs) , Manufacturing Lead, Drug Substance Manufacturing, Cell Culture Manufacturing, Upstream and Downstream Processing, 2.5 kL Harvest, Scale-up and Tech Transfer, Filtration and Chromatography, Purification Techniques, Process Validation, Bioprocess Control Systems (SCADA), Risk Management in Biomanufacturing, Root Cause Analysis (RCA), Deviation Management
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Deputy ManagerSerum Institute Of India Pvt. Ltd. Apr 2019 - Mar 2021Pune Area, IndiaDSP operation of commercial/ validation batches as per production schedule.Routine qualification of all equipment of DSP area including compliance.Handling of change control and deviation system.Preparation and revision of BMRs, SOPs, Checklists and Log Sheets.Product changeover planning and execution of batches for different products on campaign basis.Communicates directly with QA/ QC to ensure effective participation implementation of QA policies and Procedures. -
Assistant ManagerSerum Institute Of India Pvt. Ltd. Mar 2016 - Apr 2019Pune Area, IndiaWorking in Manufacturing of Recombinant DNA product and derivative.Responsibility includes scale up ,filter sizing, manufacturing support for process troubleshooting.Writting process Document ,handling change control ,deviation and batch manufacturing recordInvolved in Product change over in multiproduct facility on campaign basis.
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Executive OfficerSerum Institute Of India Ltd Aug 2012 - Mar 2016Pune Area, IndiaInvolved in Equipment qualification.involved in cause investigation in critical Deviation .
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Research AssociateIntas Pharmaceuticals Mar 2011 - Aug 2012Ahmedabad Area, IndiaResearch Associate in DSP responsible for development and optimization of Chromatography, filtration ,viral filtration process integration to meet desired product quality requirement.Support in experimental plans and execution of day to day activities.Experience in process development ,recording raw data and ensuring proper recording of experimental details procedures, observation and result in lab note book.Responsibility including preparation of SOPs,development report (PDR),TTD etc.
Jagdish Shinde Skills
Jagdish Shinde Education Details
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Institute Of Chemical Technology (Formerly Udct Mumbai)Bioprocess Technology -
Vainteya Vidyalalya And Jr.College NiphadHsc
Frequently Asked Questions about Jagdish Shinde
What company does Jagdish Shinde work for?
Jagdish Shinde works for Curateq Biologics
What is Jagdish Shinde's role at the current company?
Jagdish Shinde's current role is Manager- Manufacturing Compliance Specialist at CuraTeQ Biologics.
What is Jagdish Shinde's email address?
Jagdish Shinde's email address is ja****@****ail.com
What schools did Jagdish Shinde attend?
Jagdish Shinde attended Institute Of Chemical Technology (Formerly Udct Mumbai), Rajiv Gandhi University Of Health Sciences, Vainteya Vidyalalya And Jr.college Niphad.
What skills is Jagdish Shinde known for?
Jagdish Shinde has skills like Excellent Communication Skill, Strong Inerpersonal Skill, Analytical And Logical Thinking, Decisive, Mentoring Of Junior Members.
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Jagdish Shinde
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Jagdish Shinde
Pune1gmail.com
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