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Summary

 developmental Research Scientist with > 8 yrs of experience in novel & advanced Vaccines & Drug Delivery technologies  team Member- Pharmaceutical and biotechnological Product Development technologies with Postdoctoral experience in developing parenteral and non-invasive (oral and transdermal) dosage form design.  cGMP Manufacturing of injectable conjugate and combination vaccine product(s)  conjugate vaccine Formulation development and stability platform technologies  strong theoretical and practical knowledge in proof of concept studies in novel Drug Delivery Product Development using quality by design (qbd) Design of Experiments (does), Drug Delivery systems modelling for improved performance.  novel Formulations of Protein drugs/biotech products/combination product  experience in R&D environment with feasibility studies, early stage of Pharmaceutical Product Development, scale up, Technology transfer activities  strong interest in translational R&D activities and Technology transfer from diverse fields to Pharmaceutical or medical Product Development in order to optimize development and speedy delivery of products to market  excellent team playing capability and ability to meet challenges and deadlines.  intellectual achievements – 20+ articles (international journals), 12+ abstract (international conferences), 3 eu Patents (under application), + 2 book chapter (international)  good Communication and Project Management skills.

Experiences

Current Experience

  • Manager-Formulation Development


    Since April 2013
    Formulation R&D activities in a conjugate vaccine department (hib, pneumo and maningococcal conjugate vaccine) for parenteral conjugate vaccine Product Development.  Troubleshooting in Formulation related problems in combination vaccine such as pentavalent vaccine  improving stability of hib-tt conjugates in pentavalent vaccine Formulations.  significantly improving the adsorption of individual antigens i.e. diptheria, tetanus and hbsag and minimising the dosage regimen for parenteral Vaccines.  supporting assistant and deputy manager in Preclinical Formulation development and proof of concept studies.  Formulation R&D activities in a conjugate vaccine department (Hib, Pneumo and Maningococcal conjugate vaccine) for Parenteral conjugate vaccine product development.  Troubleshooting in Formulation related problems in combination vaccine such as Pentavalent vaccine  Improving stability of Hib-TT conjugates in pentavalent vaccine formulations.  Significantly improving the adsorption of individual antigens i.e. Diptheria, tetanus and HbsAg and minimising the dosage regimen for parenteral vaccines.  Supporting Assistant and Deputy Manager in preclinical formulation development and proof of concept studies.

Past Experience

  • Scientist

    September 2011 --- April 2013
     leading Formulation team involving in designing and development of platform technologies for thermo-stabilization of vaccine Formulations using different strategies including particle designing, encapsulation in microspheres, and industrial drying for oral delivery of rotavirus vaccine  significantly reducing the distribution cost and footprints of existing vaccine by implementing a new viable Packaging technology  managing project independently to obtain successful results, supporting Associate Scientist in Preclinical Formulation development and proof of concept studies.  perform stability studies as per ich and who guidelines, data generation for filing, & generation of product specifications.  Troubleshooting in Formulation related problems.  pre-Formulation and Formulation development studies for final vaccine Product Development using quality by design(qbd), Design of Experiments (does), factorial design (fd) approach.

  • Science Foundation Ireland (SFI) Research Fellow

    January 2009 --- January 2011
     design localized injectable Nanoparticles made of extracellular matrix based Biomaterials for intervertebral disc regeneration.  developed and optimized microspheres/Nanoparticles for aerosolized Drug Delivery (aerogen pvt. ltd.).  as Formulation development Scientist, worked on natural Biomaterials based micro and Nanoparticles for therapeutic (Protein/Gene/sirna) delivery.  worked closely with mylan int. pvt. ltd. in relation to their Formulation optimization process.  assisted and supported ph.d. students for their Characterization and animal studies.

  • Assistant Manager (NDDS)

    January 2008 --- January 2009
     pre-Formulation study design and experiments for injectable (sterile) Formulations for anticancer drugs  while working in process and Product Development Lab acquired the Training in Formulation optimization, scale-up technology for injectables and particles based oral products.  ich stability studies, data generation for filing, & generation of product specifications.  Troubleshooting in Formulation related problems.  fabrication of different batches as a part of nda & anda filings to us, european and other regulated markets

  • Postdoctoral Research Scientist

    December 2006 --- June 2008
     working in a vaccine development Research team as Formulation Scientist for developing nano/micro particulate based vaccine delivery for hepatitis c and viral diarrhea in larger animals like sheeps, cattles etc.

Knowledge

LinkedIn Assessment :
NanotechnologyBiomaterialsFormulationANDAQuality by DesignLaboratoryPharmacokineticsBiotechnologyUV/VisPatentsDrug DevelopmentIn VivoPharmaceutical IndustryHPLCGMPGood Laboratory Practice (GLP)Drug DiscoveryLife SciencesRegulatory affairsClinical DevelopmentSOPPharmaceuticsFormulation developmentDrug DeliveryLyophilizationBiopharmaceuticalsR&DVaccinesGene DeliveryControlled ReleaseNanoparticlesLiposomesMicrospheresEarly DevelopmentFeasibility StudiesScale UpTechnology transfer

Education

  • Ph D in Pharmaceutics and NDDS from Dr. H. S. Gour University Sagar INDIA in 2006
  • M. Pharm in Pharmaceutics from Department of Pharmaceutical Sciences Dr. HS Gour University in 2001
  • B. Pharm. in Pharmaceutical Sciences from Department of Pharmaceutical Sciences, Dr. HS Gour University Sagar in 1999

Training and Certification

  • Radiation Safety Course by University of Saskatchewan in 0000 Certification

Area / Region

Pune, Maharashtra, India

Others

Driving License
  • No

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