Experience

Savient Pharmaceuticals, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Principal Scientist

  • Oct 2012 - Present

  As part of a team provided support for Biologics manufacture, as well as supervised the development and validation of the several methods described below, using CROs/CMOs, for process development, product/ impurity characterization, lot release and stability testing of marketed Protein drug, Krystexxa (PEG-Uricase) as well as the Uricase raw material to fulfill post approval requirements and commitments made to FDA and EMA. ELISA to quantify human recombinant Lysozyme, a process impurity… Show more As part of a team provided support for Biologics manufacture, as well as supervised the development and validation of the several methods described below, using CROs/CMOs, for process development, product/ impurity characterization, lot release and stability testing of marketed Protein drug, Krystexxa (PEG-Uricase) as well as the Uricase raw material to fulfill post approval requirements and commitments made to FDA and EMA. ELISA to quantify human recombinant Lysozyme, a process impurity present in Uricase, protein (Uricase) quantitation by UV280 and HPLC-Anion Exchange Chromatography, assessment of the deamidation status of Uricase & PEG-Uricase using IsoQuant kit from Promega, assessment of the oxidation state of Uricase and PEG-Uricase using Mass Spectrometers, cIEF characterization of Uricase and determination of the Molar Absorptivity constant of Uric Acid Show less As part of a team provided support for Biologics manufacture, as well as supervised the development and validation of the several methods described below, using CROs/CMOs, for process development, product/ impurity characterization, lot release and stability testing of marketed Protein drug, Krystexxa (PEG-Uricase) as well as the Uricase raw material to fulfill post approval requirements and commitments made to FDA and EMA. ELISA to quantify human recombinant Lysozyme, a process impurity… Show more As part of a team provided support for Biologics manufacture, as well as supervised the development and validation of the several methods described below, using CROs/CMOs, for process development, product/ impurity characterization, lot release and stability testing of marketed Protein drug, Krystexxa (PEG-Uricase) as well as the Uricase raw material to fulfill post approval requirements and commitments made to FDA and EMA. ELISA to quantify human recombinant Lysozyme, a process impurity present in Uricase, protein (Uricase) quantitation by UV280 and HPLC-Anion Exchange Chromatography, assessment of the deamidation status of Uricase & PEG-Uricase using IsoQuant kit from Promega, assessment of the oxidation state of Uricase and PEG-Uricase using Mass Spectrometers, cIEF characterization of Uricase and determination of the Molar Absorptivity constant of Uric Acid Show less



Prolong Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Scientist III

  • May 2011 - Jan 2012

  Involved in the research and development of second generation PEGylated proteins for human therapy. • Optimized reaction conditions for PEGylation of a Cytokine and partially purified PEG-Cytokines. • Developed SDS-PAGE methods for the characterization of PEGylated Cytokines and quantitation of low levels of non-PEGylated free Cytokine as well as impurities. • Established HPLC-Anion Exchange method for characterization of PEGylated Cytokines. • Developed methods to determinate the… Show more Involved in the research and development of second generation PEGylated proteins for human therapy. • Optimized reaction conditions for PEGylation of a Cytokine and partially purified PEG-Cytokines. • Developed SDS-PAGE methods for the characterization of PEGylated Cytokines and quantitation of low levels of non-PEGylated free Cytokine as well as impurities. • Established HPLC-Anion Exchange method for characterization of PEGylated Cytokines. • Developed methods to determinate the number of PEGs attached to a Cytokine molecule. • Prepared Sepharose 4B-Cytokine affinity matrix and purified anti-Cytokine antibodies for ELISA. • Optimized ELISA methods to quantify non-PEGylated & PEGylated Cytokine in PK/ PD plasma samples and analyzed samples. • Wrote SOPs for all the above developed methods. • Designed, wrote protocol and managed ICH stability study of PEGylated cytokines and analyzed samples. Show less Involved in the research and development of second generation PEGylated proteins for human therapy. • Optimized reaction conditions for PEGylation of a Cytokine and partially purified PEG-Cytokines. • Developed SDS-PAGE methods for the characterization of PEGylated Cytokines and quantitation of low levels of non-PEGylated free Cytokine as well as impurities. • Established HPLC-Anion Exchange method for characterization of PEGylated Cytokines. • Developed methods to determinate the… Show more Involved in the research and development of second generation PEGylated proteins for human therapy. • Optimized reaction conditions for PEGylation of a Cytokine and partially purified PEG-Cytokines. • Developed SDS-PAGE methods for the characterization of PEGylated Cytokines and quantitation of low levels of non-PEGylated free Cytokine as well as impurities. • Established HPLC-Anion Exchange method for characterization of PEGylated Cytokines. • Developed methods to determinate the number of PEGs attached to a Cytokine molecule. • Prepared Sepharose 4B-Cytokine affinity matrix and purified anti-Cytokine antibodies for ELISA. • Optimized ELISA methods to quantify non-PEGylated & PEGylated Cytokine in PK/ PD plasma samples and analyzed samples. • Wrote SOPs for all the above developed methods. • Designed, wrote protocol and managed ICH stability study of PEGylated cytokines and analyzed samples. Show less



Enzon Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Scientist III

  • Jan 2003 - Jan 2011

  Participated in the complete development life cycle of two PEGylated protein drugs and developed Biosimilar/ Biobetter drug products. Supervised a team of Ph.D./ M.S. Analytical Scientists and led the team to develop & validate many cGMP methods and transferred them to internal process development & QC departments, cGMP CMOs (LONZA and others) & Partners (Sigma-Tau Pharmaceuticals). Also performed CMC characterization of E. coli derived drug substances for BLA submission & characterized… Show more Participated in the complete development life cycle of two PEGylated protein drugs and developed Biosimilar/ Biobetter drug products. Supervised a team of Ph.D./ M.S. Analytical Scientists and led the team to develop & validate many cGMP methods and transferred them to internal process development & QC departments, cGMP CMOs (LONZA and others) & Partners (Sigma-Tau Pharmaceuticals). Also performed CMC characterization of E. coli derived drug substances for BLA submission & characterized degradation products in PEGylated/ non-PEGYlated protein therapeutics for regulatory submission. Performed stability/ forced degradation studies on drug substances and drug Products and participated in process optimization for large-scale commercial Manufacturing of E. coli derived proteins, under cGMP/GLP conditions.

• Associate Director

  • Sep 2001 - Dec 2002

  Established and maintained cGMP/ GLP laboratory Laboratory for Protein Characterization and process development. Maintained marketed Protein Therapeutics, developed process, provided technical solutions relating to operational variances, out of specification, and failure investigations. Wrote reports for regulatory submission.



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Laboratory Manager

  • Apr 1998 - Sep 2001

  Established a Research & Development Laboratory for developing new specialty products for sale in Fisher BIOREAGENTS Catalog and led a group of Scientists. Was part of the team that built a facility to manufacture specialty products. Several new products were added to the catalog. Established a Research & Development Laboratory for developing new specialty products for sale in Fisher BIOREAGENTS Catalog and led a group of Scientists. Was part of the team that built a facility to manufacture specialty products. Several new products were added to the catalog.