CDMO CGT experience with a focus on analytical method development, tech transfer, validation, and regulatory filings
CMC
Quality & Compliance
Regulatory
Joshua brings to Dark Horse his years of expertise in analytical method development, tech transfer and validation. He is also well versed in several methods used to support quality control of gene therapy products.
Josh’s analytical background has also informed his authorship of regulatory filings. Josh’s DHC client projects include a variety of CMC/manufacturing regulatory projects, from pre-IND and INDs to IMPDs and CTAs.
In 2015, Josh joined Florida Biologix/Brammer Bio, now a part of Thermo Fisher Scientific’s Viral Vector Services, as a member in the Assay Development and Analytics department. Here he helped develop qPCR- and ELISA- based methods for several clients. Soon after, he transferred into the Quality Control department where he performed cell-based, nucleic acid-based, protein-based and chemistry-based methods to support quality control of gene therapy products being developed and manufactured on site. He also helped conduct qualifications and validations for methods used in routine testing.
In 2018, Josh moved to Boston to help set up the Quality Control labs at Thermo Fisher Scientific’s new Cambridge manufacturing site. He worked closely with lab planning and implementation of the instruments in the QC labs as well as the training of new analysts. Joshua became part of the Analytical Method/Instrument Validation department, where he wrote protocols, trained analysts, and compiled data for final summary reports to support the validation of several different types of analytical methods. He was QC Lead for several clients and managed the tech transfer of methods being used to support the manufacturing of their products.
Thermo Fisher Scientific Viral Vector Services
Lead Scientist
Quality Control ValidationScientist
Assay Development and Analytics/Quality Control
University of North Florida
B.S. in Biology
