Experience

Molecular Templates

• United States
• Biotechnology Research
• 1 - 100 Employee

• Downstream Process Development Scientist

  • Oct 2018 - Present

  United States Downstream Process Development of novel drugs for cancer treatment through implementation of Single Use Bio Process Systems.

• GMP Scientist

  • Oct 2018 - Jan 2020

  Austin, Texas Area



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Scientist II

  • Oct 2017 - Jun 2018

  Austin, Texas Area Involved in the oversea transfer of thermofisher technology and molecular biology products. Responsible for the formulation and testing of various reagents for qPCR and sample preparation applications including PCR master mixes, nucleic acid purification, and internal positive controls for use in various workflows such as veterinary diagnostics, USDA-certified, and custom products. •Perform QC analysis and testing for all formulations. •Wide use of several PCR systems such as ViiA7… Show more Involved in the oversea transfer of thermofisher technology and molecular biology products. Responsible for the formulation and testing of various reagents for qPCR and sample preparation applications including PCR master mixes, nucleic acid purification, and internal positive controls for use in various workflows such as veterinary diagnostics, USDA-certified, and custom products. •Perform QC analysis and testing for all formulations. •Wide use of several PCR systems such as ViiA7, 7900, 7500 (fast and standard mode), Step-One-Plus. •Utilize multiple analytical, biochemist and molecular biology techniques, including RT PCR, HPLC, HPIC, fragment analysis, spectrophotometry, pH, conductivity meters, agilent bioanalyzer •Perform complex sample preparation procedures such as large-scale PCR Master Mixes in environmentally Controlled rooms. •Troubleshoot manufacturing and quality control activities. •Revise and edit existing manufacturing documents. •Prioritize and schedule work to ensure on-time delivery. •Create and maintain Batch Records as per Thermo Fisher Scientific quality policy. •Adhere to ISO guidelines, USDA regulations. Show less



Luminex Corporation / Biodefense & Protein Diagnostics

• R&D scientist

  • Nov 2015 - Dec 2016

  Austin, Texas Protein Assay Development (Diagnostic/Biodefense). Involved in the Investigation and development of a XMAP-microsphere based assay to detect IgM response to Zika, Chikungunya, Dengue, West Nile Virus, among other mosquito borne viral infections. Searched, mixed and matched several NS1, envelop and VLP recombinant proteins for multiplex bead coupling design. Researched best cost effective reagents for sample prep, especially IgG depletion compounds. Optimized antigen concentration for bead… Show more Protein Assay Development (Diagnostic/Biodefense). Involved in the Investigation and development of a XMAP-microsphere based assay to detect IgM response to Zika, Chikungunya, Dengue, West Nile Virus, among other mosquito borne viral infections. Searched, mixed and matched several NS1, envelop and VLP recombinant proteins for multiplex bead coupling design. Researched best cost effective reagents for sample prep, especially IgG depletion compounds. Optimized antigen concentration for bead coupling. Simplified assay condition, assay workflow and strategies for high throughput demand. Evaluated clinical sensitivity, specificity, impact of interfering substances and cross-reactivity to ZIKA infection in hundreds of clinical samples. Performed sample processing, aliquoted and maintained record according to FDA and BSL-2 guidelines. Show less



Life Technologies

• United States
• Biotechnology Research
• 700 & Above Employee

• Scientist III

  • 2012 - 2014

  Austin, Texas Area Directed manufacturing operational activities centered around product launches at Austin site, leading 2 to 5 projects simultaneously and teams of 3 to 7. Ensured seamless transitions of new products from R&D into manufacturing, coordinating requirements definition, communications, scheduling, and risk assessments. Implemented Six Sigma principles (pFMEA). Established infrastructure for new products, including requesting part numbers, gathering label info, writing product work instructions, and… Show more Directed manufacturing operational activities centered around product launches at Austin site, leading 2 to 5 projects simultaneously and teams of 3 to 7. Ensured seamless transitions of new products from R&D into manufacturing, coordinating requirements definition, communications, scheduling, and risk assessments. Implemented Six Sigma principles (pFMEA). Established infrastructure for new products, including requesting part numbers, gathering label info, writing product work instructions, and reviewing and editing all quality control documentation. Manufactured pilot builds and performed testing. Ran and designed gauge R&R for new QCM. Conducted product cost estimates and routing hours, and performed process validations and manufacturing reviews. Readied all product deliverables for launch. Wrote project reports Show less



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr. Scientist

  • 2009 - 2012

  Austin, Texas Coordinated key support for R&D department in areas of in-deep product specifications development, process risk assessment, gauge R&R, assay development, and process transfer verification/validation. Led core team in development of life technology PCR catalog products, including SYBR Select Master Mix, Platinum Multiplex Master Mix, and multiple stand-alone PCR Master mix formulations. Partnered with stakeholders to review and align VOC with product requirements and specifications. Conducted… Show more Coordinated key support for R&D department in areas of in-deep product specifications development, process risk assessment, gauge R&R, assay development, and process transfer verification/validation. Led core team in development of life technology PCR catalog products, including SYBR Select Master Mix, Platinum Multiplex Master Mix, and multiple stand-alone PCR Master mix formulations. Partnered with stakeholders to review and align VOC with product requirements and specifications. Conducted risk assessments, operation reports, and pFMEA. Created documentation for all activities, including infrastructure and internal manufacturing documentation and customer facing documents Show less



GE HealthCare

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Scientist

  • 2004 - 2009

  Piscataway, NJ Led process development and transfer activities for protein/reagents development group, with focus on molecular biology enzymes or DNA/RNA polymerases family (including fermentation and purification of enzymes, protein expression and enzyme activity enhancement, and increase of enzyme stability. Implemented new purification methods to improve processes. Oversaw wide range of molecular biology and epigenetic research projects. Designed and conducted statistical experiments for screening and… Show more Led process development and transfer activities for protein/reagents development group, with focus on molecular biology enzymes or DNA/RNA polymerases family (including fermentation and purification of enzymes, protein expression and enzyme activity enhancement, and increase of enzyme stability. Implemented new purification methods to improve processes. Oversaw wide range of molecular biology and epigenetic research projects. Designed and conducted statistical experiments for screening and optimization of parameters impacting quality and stability of lyophilized PCR product. Managed process scale ups, including training and trial builds. Revised and improved SOP and work instructions. Wrote publications reviews and analyses of novel findings. Provided technology and data analysis coaching Show less



Amersham Biosciences, R&D Life Sciences

• Senior Research Associate

  • 2000 - 2004

  Piscataway, NJ Optimized analytical techniques for detection of difficult-to-express protein in crude cell homogenate and purified material, including SDS-PAGE, Western Blot, ELISA, and IEF. Managed various research projects. Coordinated protein purification process (IEC, HIC, SEC, Affinity) using Akta system and Unicorn platform, Oversaw process scale-up, validation, and verification. Determined technical specifications for new products. Characterized enzyme formulations.



Institute of Tropical Medicine Pedro Kouri, Cuba

• Reseach Associate

  • 1995 - 1998

  -Contributed to the study of biochemical and genetics mechanisms of insecticide resistance in Culex, Aedes, and Anopheles mosquitoes, research of significant relevance to control mosquito-transmitted disease outbreaks in Cuba and Latin American countries. -Worked on the purification and partial characterization of antigenic-proteins derived from excretory/secretory extracts of Fasciola hepatic, used for the early diagnosis of the infection in animals and humans (thesis of… Show more -Contributed to the study of biochemical and genetics mechanisms of insecticide resistance in Culex, Aedes, and Anopheles mosquitoes, research of significant relevance to control mosquito-transmitted disease outbreaks in Cuba and Latin American countries. -Worked on the purification and partial characterization of antigenic-proteins derived from excretory/secretory extracts of Fasciola hepatic, used for the early diagnosis of the infection in animals and humans (thesis of degree) -Evaluated and implemented best practices in clinical laboratory, to improve quality on screening/monitoring of infectious blood diseases. Show less