Experience

Encodia, Inc.
• Information Technology & Services
• 1 - 100 Employee
• Scientist I

  • Sep 2022 - Dec 2022

Ambrx
• United States
• Biotechnology Research
• 1 - 100 Employee
• Associate Scientist

  • Mar 2021 - Sep 2022

Pfenex
• Iran
• Education Administration Programs
• Associate Scientist

  • Jun 2018 - Mar 2021


aTyr Pharma

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Scientist

  • Jan 2018 - May 2018

• Senior Research Associate

  • Sep 2015 - Jan 2018


Applied Proteomics, Inc.
• United States
• Biotechnology Research
• 1 - 100 Employee
• Research Associate

  • Feb 2015 - Sep 2015

Prometheus
• Ukraine
• E-Learning Providers
• 1 - 100 Employee
• Senior Research Associate

  • Jan 2011 - Feb 2015


Halozyme Therapeutics, Inc.

• Senior Research Associate

  • May 2007 - Oct 2010

  Formulated drugs in support of preclinical studies and developed liposomes for sustained release of enzymes. Coordinated with multiple departments for tissue and blood collections, and associated analytics. ➢ Designed, developed aseptic techniques and methods to improve liposomal encapsulation efficiency of rHuPH20 for sustained released. Activity was recovered. Payload increased from fg to mg. Product showed decrease in tumor mass when injected in-vivo. ➢ Designed, and developed and… Show more Formulated drugs in support of preclinical studies and developed liposomes for sustained release of enzymes. Coordinated with multiple departments for tissue and blood collections, and associated analytics. ➢ Designed, developed aseptic techniques and methods to improve liposomal encapsulation efficiency of rHuPH20 for sustained released. Activity was recovered. Payload increased from fg to mg. Product showed decrease in tumor mass when injected in-vivo. ➢ Designed, and developed and coordinated characterization methods to initiate stability studies establishing various stability points in plasma or formulation buffer by ELISA, HPLC, R/NR GELS, and endotoxin. ➢ Designed and developed process and formulations to reconstitute various co-formulations in support of CRO such as Baxter and Roche preclinical studies. Coordinated and aseptically formulated over 60 API used in animal studies for a go-no-go POC. Reported and presented progress to management, other departments to assist in decision-making. Show less Formulated drugs in support of preclinical studies and developed liposomes for sustained release of enzymes. Coordinated with multiple departments for tissue and blood collections, and associated analytics. ➢ Designed, developed aseptic techniques and methods to improve liposomal encapsulation efficiency of rHuPH20 for sustained released. Activity was recovered. Payload increased from fg to mg. Product showed decrease in tumor mass when injected in-vivo. ➢ Designed, and developed and… Show more Formulated drugs in support of preclinical studies and developed liposomes for sustained release of enzymes. Coordinated with multiple departments for tissue and blood collections, and associated analytics. ➢ Designed, developed aseptic techniques and methods to improve liposomal encapsulation efficiency of rHuPH20 for sustained released. Activity was recovered. Payload increased from fg to mg. Product showed decrease in tumor mass when injected in-vivo. ➢ Designed, and developed and coordinated characterization methods to initiate stability studies establishing various stability points in plasma or formulation buffer by ELISA, HPLC, R/NR GELS, and endotoxin. ➢ Designed and developed process and formulations to reconstitute various co-formulations in support of CRO such as Baxter and Roche preclinical studies. Coordinated and aseptically formulated over 60 API used in animal studies for a go-no-go POC. Reported and presented progress to management, other departments to assist in decision-making. Show less



CovX

• Biotechnology Research
• 1 - 100 Employee

• Research Associate 2

  • Feb 2005 - May 2007

  Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols. ➢ Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols through a cross picture process design. o Characterized formulations by several assays: (Visual-turbidity and color, R/NR gels-purity and… Show more Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols. ➢ Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols through a cross picture process design. o Characterized formulations by several assays: (Visual-turbidity and color, R/NR gels-purity and weight, SEC/RP HPLC-purity, size, and charge, ANS-kinetic binding, ELISA-qualitative and quantitative, UV/VIS-kinetics and concentration, DSC- stability and kinetics, IEF-charges and purity, Osmolarity, and Endotoxin by CTL). ➢ Developed and optimized ELISA assays by testing for multiple external conditions and reagents (conjugation, immunogenicity, potency, TK and PK). Authored STMs and transferred validated methods to CTL along with critical reagents. Trained new personnel internally and externally (CRO) developed, assisted, and trained others with the development of other assays ➢ Developed stability indicating methods and tested API, collected and trended data to optimize formulations. Show less Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols. ➢ Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols through a cross picture process design. o Characterized formulations by several assays: (Visual-turbidity and color, R/NR gels-purity and… Show more Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols. ➢ Developed liquid formulations for peptide conjugated monoclonal antibody API and associated process intermediates by designing and performing stability indicating protocols through a cross picture process design. o Characterized formulations by several assays: (Visual-turbidity and color, R/NR gels-purity and weight, SEC/RP HPLC-purity, size, and charge, ANS-kinetic binding, ELISA-qualitative and quantitative, UV/VIS-kinetics and concentration, DSC- stability and kinetics, IEF-charges and purity, Osmolarity, and Endotoxin by CTL). ➢ Developed and optimized ELISA assays by testing for multiple external conditions and reagents (conjugation, immunogenicity, potency, TK and PK). Authored STMs and transferred validated methods to CTL along with critical reagents. Trained new personnel internally and externally (CRO) developed, assisted, and trained others with the development of other assays ➢ Developed stability indicating methods and tested API, collected and trended data to optimize formulations. Show less



Favrille

• United States
• Pharmaceutical Manufacturing

• Qualtiy Control III

  • Nov 2002 - Feb 2005

  ➢ Successfully transferred analytical methods for QC inventory while coordinating the analysis of raw materials, in process, and final product from vendors, material management and manufacturing. Wrote SOPs, STMs and EOPs to train others in used of equipment and sample analysis. Trained new personnel. Organized formulation stability studies per ICH guidelines and tested API’s concentration and activity. Revised and reviewed data sheets and documents. Successfully participated in internal and… Show more ➢ Successfully transferred analytical methods for QC inventory while coordinating the analysis of raw materials, in process, and final product from vendors, material management and manufacturing. Wrote SOPs, STMs and EOPs to train others in used of equipment and sample analysis. Trained new personnel. Organized formulation stability studies per ICH guidelines and tested API’s concentration and activity. Revised and reviewed data sheets and documents. Successfully participated in internal and external audits by QA and the FDA. Evaluated OOT/OOS data from results collected and techniques performed. Trended all data collected. ➢ Recommended appropriate equipment and assisted in the physical validations and calibrations. Validated and Performed AKTA-FPLC, HPLC, PCR, ELISA, UV/VIS, Thermocyclers, Particle Size, Osmolality, Conductivity, TOC, BCA and pH. Performed ELISA, R/NR Gels. Tested over 150 idiotypic monoclonal antibodies (BDS) within a year. Assembled, Calibrated and Repaired equipment as needed. Organized, designed and performed IOOQ and PQ for equipment. Provide support to GMP and GLP Departments. Managed all outside contract testing labs (CROs) by creating vendor agreements and parameter when returning/reporting data to the dept. Show less ➢ Successfully transferred analytical methods for QC inventory while coordinating the analysis of raw materials, in process, and final product from vendors, material management and manufacturing. Wrote SOPs, STMs and EOPs to train others in used of equipment and sample analysis. Trained new personnel. Organized formulation stability studies per ICH guidelines and tested API’s concentration and activity. Revised and reviewed data sheets and documents. Successfully participated in internal and… Show more ➢ Successfully transferred analytical methods for QC inventory while coordinating the analysis of raw materials, in process, and final product from vendors, material management and manufacturing. Wrote SOPs, STMs and EOPs to train others in used of equipment and sample analysis. Trained new personnel. Organized formulation stability studies per ICH guidelines and tested API’s concentration and activity. Revised and reviewed data sheets and documents. Successfully participated in internal and external audits by QA and the FDA. Evaluated OOT/OOS data from results collected and techniques performed. Trended all data collected. ➢ Recommended appropriate equipment and assisted in the physical validations and calibrations. Validated and Performed AKTA-FPLC, HPLC, PCR, ELISA, UV/VIS, Thermocyclers, Particle Size, Osmolality, Conductivity, TOC, BCA and pH. Performed ELISA, R/NR Gels. Tested over 150 idiotypic monoclonal antibodies (BDS) within a year. Assembled, Calibrated and Repaired equipment as needed. Organized, designed and performed IOOQ and PQ for equipment. Provide support to GMP and GLP Departments. Managed all outside contract testing labs (CROs) by creating vendor agreements and parameter when returning/reporting data to the dept. Show less



American Peptide Company

• Quality Control Chemist

  • 2000 - 2002

  ➢ QC, QA and FORMULATION SUPPORT o Provided support to CROs, GMP and Non GMP Departments. Authored SOP and STM documents. Adhered and interpreted 21 CFR Part 11 requirements. Inspected and released Raw Materials, In Process Goods, and Finished Goods. Validated testing procedures. Wrote deviations and nonconforming materials reports. Revised and reviewed data sheets and documents. Trained new personnel. Knowledge in the use of HPLC (Shimadzu, Waters, Varian) Mass Spec (MALDI) Amino Acid… Show more ➢ QC, QA and FORMULATION SUPPORT o Provided support to CROs, GMP and Non GMP Departments. Authored SOP and STM documents. Adhered and interpreted 21 CFR Part 11 requirements. Inspected and released Raw Materials, In Process Goods, and Finished Goods. Validated testing procedures. Wrote deviations and nonconforming materials reports. Revised and reviewed data sheets and documents. Trained new personnel. Knowledge in the use of HPLC (Shimadzu, Waters, Varian) Mass Spec (MALDI) Amino Acid Analyzers (Beckman). o Assembled, Calibrated and Repaired equipment as needed. Generated and Organized trend analysis reports on material performances predicting AQL values. Redesigned and provide user improvements to the manufacturer without forfeiting warranties. ➢ VALIDATIONS o Verified and demonstrated equipment installation in accordance with the manufacturer’s recommendations. Provided tests and inspection plans that verified critical attributes of the equipment. Confirmed that the equipment will operate in accordance to the design specifications from the company and the manufacturer. Verified that the operating procedures, maintenance, cleaning, and monitoring of the equipment will consistently operate and function according to design specifications. Tested and generated data that would meet minimum standards of accuracy, linearity, and precision. ➢ PURCHASING o Generated a database for Purchasing. Created a trend analysis to predict depletion of consumables used to generate open POs that saved the company a minimum of $120,000 in less than nine months. Linked the chemical purchases to the chemical inventory database. ➢ SAFETY OFFICER o Liaison to the Fire Dept, OSHA and the EPA. Generated reports of inspections and corrected violations within specified times. Organized and controlled inventory of all chemicals and generated waste. Show less ➢ QC, QA and FORMULATION SUPPORT o Provided support to CROs, GMP and Non GMP Departments. Authored SOP and STM documents. Adhered and interpreted 21 CFR Part 11 requirements. Inspected and released Raw Materials, In Process Goods, and Finished Goods. Validated testing procedures. Wrote deviations and nonconforming materials reports. Revised and reviewed data sheets and documents. Trained new personnel. Knowledge in the use of HPLC (Shimadzu, Waters, Varian) Mass Spec (MALDI) Amino Acid… Show more ➢ QC, QA and FORMULATION SUPPORT o Provided support to CROs, GMP and Non GMP Departments. Authored SOP and STM documents. Adhered and interpreted 21 CFR Part 11 requirements. Inspected and released Raw Materials, In Process Goods, and Finished Goods. Validated testing procedures. Wrote deviations and nonconforming materials reports. Revised and reviewed data sheets and documents. Trained new personnel. Knowledge in the use of HPLC (Shimadzu, Waters, Varian) Mass Spec (MALDI) Amino Acid Analyzers (Beckman). o Assembled, Calibrated and Repaired equipment as needed. Generated and Organized trend analysis reports on material performances predicting AQL values. Redesigned and provide user improvements to the manufacturer without forfeiting warranties. ➢ VALIDATIONS o Verified and demonstrated equipment installation in accordance with the manufacturer’s recommendations. Provided tests and inspection plans that verified critical attributes of the equipment. Confirmed that the equipment will operate in accordance to the design specifications from the company and the manufacturer. Verified that the operating procedures, maintenance, cleaning, and monitoring of the equipment will consistently operate and function according to design specifications. Tested and generated data that would meet minimum standards of accuracy, linearity, and precision. ➢ PURCHASING o Generated a database for Purchasing. Created a trend analysis to predict depletion of consumables used to generate open POs that saved the company a minimum of $120,000 in less than nine months. Linked the chemical purchases to the chemical inventory database. ➢ SAFETY OFFICER o Liaison to the Fire Dept, OSHA and the EPA. Generated reports of inspections and corrected violations within specified times. Organized and controlled inventory of all chemicals and generated waste. Show less