Irina Kostareva

Irina Kostareva Email and Phone Number

Senior Scientist at Laureate Pharma @ Laureate Pharma
Irina Kostareva's Location
Bronx, New York, United States, United States
Irina Kostareva's Contact Details

Irina Kostareva work email

Irina Kostareva personal email

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About Irina Kostareva

Employment with a firm, in the pharmaceutical and/orbiotechnology sector, where I can make use of my substantial technical experience and contribute to the organization’s success and growth. Extensive GLP/GMP experience in antibody, protein and peptide purification, conjugation, production and analytical methods development. Proficient in all technical areas of product development including research, formulation, stability studies, analytical, quality control methods, immunoassays and cell/particle based assays development and validation, technology transfer, regulatory affairs, CMC documentation generation, clinical and manufacturing supervision. Innovative business development professional with two years experience in sales and marketing. Excellent managerial, analytical, technical and communication skills. Compelling speaker with exceptional presentation skills proficient in conducting technical seminars and discussions with target customer groups. Strong, self-motivated leader with a proven track record of making consistent and significant contributions to organizational success.Specialties: Protein and peptide chemistry, purification, conjugation, characterization, analysis, manufacturing. Process, analytical methods development, validation, transfer to CMO. Sales and marketing

Irina Kostareva's Current Company Details
Laureate Pharma

Laureate Pharma

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Senior Scientist at Laureate Pharma
Irina Kostareva Work Experience Details
  • Laureate Pharma
    Senior Scientist
    Laureate Pharma Jan 2011 - Present
     Responsible for the protein purification process development, optimization, scale-up and transfer to the manufacturing with necessary documentation.  Developed polishing steps for the quality improvement of final product  Participation in GMP production, process and viral clearance validation.
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  • Atoll-Bio, Usa
    Business Development Manager, Senior Technical Consultant
    Atoll-Bio, Usa Apr 2008 - Apr 2010
     Responsible for marketing and sales of Atoll chromatography products in the US Developed applications and provide technical service for Atoll products with emphasis on protein drug discovery, protein analysis and upstream and downstream process development Expanded Atoll presence at 21 new accounts with greater than 500% revenue increase Conducted technical talks, poster presentations and round-table discussions at four scientific conferences  Proficient in all aspects of consultative technical sales
  • Elusys Therapeutics, Inc. Pine Brook, Nj
    Director, Process Development
    Elusys Therapeutics, Inc. Pine Brook, Nj Jan 2006 - Feb 2008
    Parsippany, New Jersey, Us
    Director, Process Development Department  Responsible for monoclonal antibody (MAb) purification process development, scale-up, analysis, formulation, stability study, transfer to CMO and CMC documentation generation Developed and scaled-up MAb modification and conjugation processes  Devised scalable MAb conjugate purification process  Developed immunoassays and cell-based assays to evaluate potency and concentration of purified and conjugated antibody. Developed analytical methods for process control and characterization of in-process and final product. Produced therapeutic grade MAbs and MAb conjugates Transferred MAb purification processes for industrial production and oversaw development of downstream processes at CMO, created and reviewed GMP documents Led a team of 10 scientists
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  • Bayer Diagnostics, Tarrytown, Ny
    Senior Scientist, Chemistry R&D Department
    Bayer Diagnostics, Tarrytown, Ny Mar 2004 - Sep 2005
    New York, Us
     Responsible for autimated clinical diagnostic assay modification, transfer and validation  Introduced various methods onto new clinical analyzers with proper validation and documentation  Optimized reagents for the automated pancreatic lipase diagnostic assay which resulted in reproducible assay performance
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  • Mojavie Therapeutics, Inc
    Senior Scientist
    Mojavie Therapeutics, Inc May 2001 - Nov 2003
     Responsible for analytical QC method development for peptide-protein complexes, protein purification and conjugation process development  Developed and characterized therapeutic vaccine formulation Developed and validated HPLC-based QC methods including product release tests Developed HPLC methods to monitor peptide, protein and oligonucleotide modification Developed HPLC methods to characterize therapeutic vaccines and monitor their stability Developed purification process and performed technology transfer to CMO for GMP production Designed and scaled-up peptide-protein and oligonucleotide-protein conjugation processes Generated regulatory filings, appropriate SOPs and reports Supervised two research associates
  • Ortho-Clinical Diagnostics, A Johnson And Johnson Company,
    Senior Scientist, Aids/Hepatitis R&D Department
    Ortho-Clinical Diagnostics, A Johnson And Johnson Company, May 1995 - Apr 2001
     Responsible for ELISA development and optimization based on the development, validation and transfer of purification processes for protein conjugates Successfully designed, scaled-up and transferred conjugation processes for proteins and purification processes for conjugates, MAbs and associated fragments used in HTLV, HIV and HCV ELISA.  Developed antibody fragmentation and protein conjugation processes Generated technical documentation, regulatory filings and and reviewed GMP documents  Transferred technology to manufacturing andsupervised clinical lots production Developed, validated and transferred analytical quality control methods for intermediate and final products Developed QC test methods, SOPs, validation and stability protocols and reports Designed and conducted FMEA studies for purification and conjugation processes Designed and conducted stability studies for activated horseradish peroxidase (HRP), conjugates, MAb and associated fragments Designed training programs and trained technical staff on newly developed methods and procedures  Supervised up to seven scientists and technicians
  • Immunomedics
    Scientist
    Immunomedics Oct 1993 - Feb 1995
    Morris Plains, New Jersey, Us
     Developed and improved purification processes for MAbs and their fragments  Scaled up MAbs and their fragments purification processes  Liaised with Regulatory Affairs to develop critical validation data for regulatory filings Generated technical documentation, sections in regulatory filing documents for BLA
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  • State Research Institute Of Biopreparations
    Senior Research Scientist, St. Petersburg, Russia
    State Research Institute Of Biopreparations Jan 1991 - Jun 1993
     Isolated and purified recombinant HIV-1 p24 and gp160, Interleukins-1 alpha and beta, human erythrocyte acetylcholinesterase, monoclonal and polyclonal antibodies Supervised manufacturing of recombinant Interleukin-1 beta from fermentation to purified end product Purified influenza, parainfluenza, RS viruses Developed immunoenzyme diagnostic tests and protocols for HIV-1

Irina Kostareva Skills

Protein Chemistry Gmp Chromatography Technology Transfer Purification Hplc Validation Drug Discovery Monoclonal Antibodies Biotechnology Assay Development Characterization Elisa Immunoassays Biochemistry Drug Development Protein Purification Fermentation Process Simulation Bioanalysis Sop Biopharmaceuticals R&d Analytical Chemistry Sds Page Peptides Filtration Lifesciences Vaccines Regulatory Affairs Chemistry Antibodies Molecular Biology Pharmaceutical Industry Proteomics Formulation Fda Commercialization Mass Spectrometry Protein Expression Cell Culture Microbiology Glp Pcr Cell Immunology Lims Analytical Methods Development Dna

Irina Kostareva Education Details

  • Academy Of Science, St. Petersburg, Russia
    Academy Of Science, St. Petersburg, Russia
    Chemistry

Frequently Asked Questions about Irina Kostareva

What company does Irina Kostareva work for?

Irina Kostareva works for Laureate Pharma

What is Irina Kostareva's role at the current company?

Irina Kostareva's current role is Senior Scientist at Laureate Pharma.

What is Irina Kostareva's email address?

Irina Kostareva's email address is ir****@****ios.com

What schools did Irina Kostareva attend?

Irina Kostareva attended Academy Of Science, St. Petersburg, Russia.

What skills is Irina Kostareva known for?

Irina Kostareva has skills like Protein Chemistry, Gmp, Chromatography, Technology Transfer, Purification, Hplc, Validation, Drug Discovery, Monoclonal Antibodies, Biotechnology, Assay Development, Characterization.

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