Experience

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  Panacea biotec ltd

  Jan 2003 - Jan 2004

  Research microbiologist

  Vaccine R & D- Trained in cGMP and GLP Practices for the manufacture of Pharmaceuticals/Biologicals as per WHO Guidelines.- Established the vaccine R&D lab for pre-clinical development and validation of upstream and downstream processes for products in pipeline.- Purchased Equipment and Material based on quotations, comparative technical evaluation and supplier approval.- Procured Bacterial strains from ATCC and NIBSC. Prepard Cell Banks – Liquid Glycerol Stocks and Lyophilized, making immunization schedules and raising antisera against the above strains in rabbits.- Standardized the protocol for the manufacture of N. meningitides Tetravalent Polysaccharide Vaccine on R & D Scale and developed SOPs for its QC.- Part of the team involved in the successful scale up of H. influenzae type b polysaccharide vaccine from R & D level to 22 L Production level Fermentor.- Part of the team involved in the setup of a WHO level GMP production facility for the manufacture of polysaccharide vaccines. The work involved planning room inventories, layouts, product and personnel flow, specifications for equipment and material and working out overall cost factors and time frames for production. Show less

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  Postgraduate institute of medical education and research

  Jan 2004 - Jan 2010

  Research scientist

  Indo German Collaborative Project, Molecular Immunology Lab, Deptartment of ImmunopathologyWorked on the role of Innate Immune responses in HIV infection with special emphasis on plasmacytoid DCs and NK Cells.

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  Hannover medical school

  Jan 2008 - Jan 2008

  Visiting scientist
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  Louisiana state university

  Jan 2010 - Jan 2011

  Post-doctoral scientist

  Explored the role of RLRs in modulating the innate immune response to neonatal respiratory viruses including RSV and HMPV.

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  Wayne state university - school of medicine

  Jan 2011 - Jan 2012

  Post-doctoral scientist

  Role of TLR2 in murine model of bacterial endophthalmitis :-My active research interests involve exploring the role of TLRs and NLRs signal transduction pathways in innate immune response against S. aureus mediated endophthalmitis in mouse models. I am also exploring various TLR ligands as potential therapeutic agents for the treatment of bacterial endophthalmitis.

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  Aaa clinical research

  Jan 2012 - Jan 2015

  Clinical research associate

  Managed and monitored late phase (Phase II to IV) clinical trials in several therapeutic areas including T2DM, Asthma, hypertension, Vaccines, Flu, SLE, Hyperlipidemia, Otitis, Pain and more.Managed Study start-ups and close-outs.Successfully hosted audits from Sponsors, Health Canada and FDARegulatory submissions and approvalsLiaised with Sponsors & CROs for ongoing and future projectsClinical Trials Agreements (Indemnification, Insurance etc.)Supported the development of new Investigator initiated research projects.Developed disruptive patient recruitment strategies, significantly improving business outcome.Assisted in development of company website Show less

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  Apotex inc.

  Jun 2015 - May 2018

  - Management and execution of early and late phase, multi-centric, global clinical trials supporting the development of Biosimilars for Hematology/Oncology indications.- Liaising with CROs, and other vendors for study design, protocol development, investigator site selection, regulatory approvals, safety labs, CTAs, insurance, data management etc.- Engaging with Contract Bio-analytical Laboratories for the development and validation of cell-based and immunoassays to demonstrate biosimilarity and assessing immunogenicity of biosimilars. Show less •Planned and executed 100+ GCP/GLP Quality audits/monitoring visits of clinical sites and bioanalytical labs to support regulatory submissions.•Represented Quality in cross-functional project teams to support clinical studies, planning projects feasibilities, project gantts and providing strategic inputs to avoid potential deficiencies in regulatory submissions.•Expeditiously trained on several enterprise software systems including Docubridge, Trackwise QMS etc.•Helped improve processes based on investigations, CAPAs, risk assessment and risk mitigation. Show less

  • Associate, Clinical Research

    Jan 2017 - May 2018

  • Auditor, Clinical Quality Assurance

    Jun 2015 - Dec 2016
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  University health network

  May 2018 - now

  - Managing cutting edge Immune/Cell therapy clinical trials at Canada's biggest hospital network, including Autologous and Off-the-shelf Allo CAR T cells, Genetically engineered TCR, TILs, Genetically Engineered Stem Cells, Decidual Stromal Cells, Virus specific Activated Cells and more.- Managing the entire cell-processing portfolio for 30+ cell therapy clinical trials in a FACT accredited setup including Apheresis ship-outs, Tumor processing and ship-outs, cryopreservation, IP receipt, LN2 vapor phase storage, dose preparation and manipulation, validations, calibrations, quality audits and more. Show less

  • Clinical Research Manager - CCRU Cell Therapy Program

    Jun 2022 - now

  • Manager, Cell Therapy Program-Cancer Clinical Research Unit, Princess Margaret Cancer Centre

    May 2018 - May 2022