Experience

GenScript

• United States
• Biotechnology Research
• 400 - 500 Employee

• Director of New Platform Development

  • Aug 2021 - Present

  Piscataway, New Jersey, United States Background Stephen Hughes New Platform Development Group Introduction Platform using nanoDNA for hospital-based self-transduction of ultrapersonal episomal or integrated gene therapies From the beginning of the gene and cell therapy revolution in 2017, the FDA has been pushing for a safe hospital-based ultrapersonal route. The route must be useful for both ultrapersonal gene editing and addition integrating gene therapy and also for ultrapersonal euchromatin chromosome episomal… Show more Background Stephen Hughes New Platform Development Group Introduction Platform using nanoDNA for hospital-based self-transduction of ultrapersonal episomal or integrated gene therapies From the beginning of the gene and cell therapy revolution in 2017, the FDA has been pushing for a safe hospital-based ultrapersonal route. The route must be useful for both ultrapersonal gene editing and addition integrating gene therapy and also for ultrapersonal euchromatin chromosome episomal replicative cell therapy. This paradigm should involve self-assembly without use of plasmids or E. coli for production, and it should not involve expensive disposable production processes for plasmid production nor expensive viral production. The process should be low cost and produce large numbers of doses and should be able to be carried out in the hospital’s gene and cell therapy areas. Goal Integrated Synthetic Chromosome Technologies Inc. and GenScript nanoDNA gene therapy production collaboration team with Rutgers Cancer Institute of NJ, Penn Health Princeton, Universal Machine and Engineering, and Calvary Robotics will produce a microfluidic device that self assembles ultrapersonal gene therapie chromosomes for episomal or euchromatin integrated routes. The microfluidic platforms will use Integrated Synthetic Chromosome Technologies Inc. equipment and GenScript reagent packs at the hospital for undefeated error-free nanoDNA particles for ultrapersonal therapeutic use. This unit will self-assemble the nanoDNA particle for a gene therapy that can be used with or without the patients’ cells. That is the ultrapersonal stem cell or patient cell for therapy can be removed and self- transduced with this nanoDNA, or the nanoDNA can be directly self-transduced at the site in the patient’s tissue. No plasmid, or plastic disposables, or oligos will be used in the unit. Gene therapy platform for manufacturing nanoDNA therapeutic product for targeted cell- specific gene expression or editing Show less



Spark Therapeutics, Inc.

• United States
• Biotechnology
• 700 & Above Employee

• Preclinical Automation Lead

  • Sep 2020 - Aug 2021



GenScript

• United States
• Biotechnology Research
• 400 - 500 Employee

• Director of Vector Manufacturing at GenScript Inc.

  • Jan 2020 - Jul 2020



Applied DNA Sciences

• Biotechnology Research
• 1 - 100 Employee

• Director of DNA Programs

  • Sep 2017 - Jan 2020

  Stoney Brook, NY Responsible for technology enabling very large-scale production of DNA using proprietary PCR methods, which allow designed DNA sequences to be produced directly from synthetic genomics. Direct automation and scale-up of PCR-based DNA programs for targeted industrial and medical partners. Designed point of care, on-demand, cGMP facility for real-time immunotherapy using rapid automated linear DNA high-level expression amplicon synthesis, assembly, amplification, and transfection for production… Show more Responsible for technology enabling very large-scale production of DNA using proprietary PCR methods, which allow designed DNA sequences to be produced directly from synthetic genomics. Direct automation and scale-up of PCR-based DNA programs for targeted industrial and medical partners. Designed point of care, on-demand, cGMP facility for real-time immunotherapy using rapid automated linear DNA high-level expression amplicon synthesis, assembly, amplification, and transfection for production of first truly personalized antigens, antibodies, TCR, and CAR T. Show less



US Department of Agriculture (USDA) Agricultural Research Service (ARS)

• Research Services
• 700 & Above Employee

• Research Molecular Biologist

  • Aug 2003 - Sep 2017

  Peoria, IL Assembled laboratory involving over one million dollars in capital expenditures to support high-throughput robotic operations for optimizing industrial yeast strains. Constructed first-in-kind integrated plasmid-based functional proteomic robotic platform to perform high-throughput cloning, transformation, expression and assay operations for screening mutagenized genes to use in engineering improved industrial yeast strains for efficient biofuel production. Developed strategies to optimize… Show more Assembled laboratory involving over one million dollars in capital expenditures to support high-throughput robotic operations for optimizing industrial yeast strains. Constructed first-in-kind integrated plasmid-based functional proteomic robotic platform to perform high-throughput cloning, transformation, expression and assay operations for screening mutagenized genes to use in engineering improved industrial yeast strains for efficient biofuel production. Developed strategies to optimize genes and improve microbial strains to convert renewable agricultural materials into sustainable commercial products. Collaborated with engineers and scientists at universities, industries, and government institutions to implement automated molecular biology protocols, develop optimized genes, create novel vectors, engineer host cell lines, support continuous screening operations, and design integrated biorefineries. Created innovative efficient high-throughput microbial gene expression systems combined with novel gene/chromosome synthesis approaches including codon optimization for automated platforms to create improved commercially viable stable industrial strains. Show less



Cell Pathways, Inc.

• Staff Scientist

  • Aug 2001 - Aug 2003

  Horsham, PA Designed and implemented a functional proteomics platform for protein kinase substrate identification and for determination of protein or small molecule binding. Used platform to express all full-length cDNA libraries isolated from cancer cell line mRNA into functional proteins to provide protein arrays for high-throughput screening to identify binding targets of compounds of interest.



Worthington Biochemical Corporation

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Research Scientist

  • Aug 2000 - Aug 2001

  Lakewood, NJ Developed and scaled up high-yield expression systems in yeast and E. coli for production of industrially and therapeutically important nucleases and proteases.

• Molecular Biology and Quality Control Manager

  • Nov 1998 - Aug 2000

  Lakewood, NJ Managed in-process and release testing of all biochemical and molecular biology products in accordance with applicable GLP and cGMP regulations. Developed and conducted assays for characterization of enzymes and related protein products utilizing more than 200 different assays. Established molecular biology group and trained personnel in latest cell biology, molecular biology and microbiology techniques.



Hudson Robotics, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Sales Manager

  • Jan 1998 - Nov 1998

  Springfield, NJ Provided sales and marketing support for laboratory automation robotic workstation integrator. Conceptualized use of robotic workstations for HT-DNA miniprep 96-well format isolation of plasmid DNA from bacteria for ELISA/bioassay high throughput screening and for drug screening scenarios.



Hoechst Marion Roussel Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Research Scientist, Neuroscience Department

  • Jan 1997 - Jan 1998

  Bridgewater, NJ Extended the application of yeast two-hybrid system to identify proteins interacting with presenilin 1 protein; engineered novel thioredoxin expression construct designed to maintain in vivo conformation of loop region of presenilin in absence of full coding region. Substantiated by Northern analyses the differential expression of genes important to bone growth identified by INCYTE electronic differential display.



Quality Biotech, Inc.

• Senior Scientist, Molecular Biology

  • Mar 1996 - Jan 1997

  Camden, NJ Developed and conducted assays to evaluate safety of biologics, specifically PCR and RT-PCR detection of viral and mycoplasma contaminants and QC-PCR quantitation of gene therapy vectors. Evaluated cell lines with respect to integration site, copy number, and sequence of expressed message to verify post-production stability; sequenced gene therapy vectors. As Study Director ensured work was conducted in compliance with GLP/GMP regulations and other applicable FDA requirements.



Hoechst Marion Roussel, Inc.,

• Postdoctoral Research Fellow, Neuroscience Department

  • Oct 1993 - Mar 1996

  Bridgewater, NJ Engineered a novel two-hybrid technology to identify protein-protein interactions involving the plaque-forming Aβ peptide implicated in Alzheimer’s disease. Employed two-hybrid technique to characterize Aβ peptide monomer-monomer interactions and to study the mechanism of these interactions by mutagenesis of the regions important to Aβ aggregation.