Josh Combs Email & Phone Number

Boulder, Colorado, United States

Fort Worth, Texas, United States

Fort Worth, Texas

Oversee all aspects of Drug Substance and Drug Product Manufacturing for XBiotech's True Human monoclonal antibody platform utilizing single use methodologies. Manage the day to day activities for 15+ direct reports split between multiple cGMP facilities. Currently oversee supply chain issues regarding clinical and pre-commercial manufacturing. Developed the Upstream and Downstream manufacturing process for XBiotech's lead antibody, currently awaiting regulatory approval. Primary author on all CMC documents relating to manufacturing and process development for FDA, EMA, and Heath Canada submissions. Performed multiple supplier quality audits as a lead subject matter expert. Served as primary point of contact during multiple on-site regulatory inspections, and was the lead voice for all manufacturing issues. Co-lead in design of new cGMP space for XBiotech's commercial manufacturing facility in Austin, Texas. Designed the process flow, and procured new process equipment from multiple vendors. Performed FAT/SAT on process equipment intended for product commercialization. Written and executed multiple viral clearance studies utilizing third party CROs. Developed novel bioreactor, and chromatography systems with on and off-site engineers. Routinely author process SOPs, Production records, and Test Plans. Written and executed Drug Substance and Drug Product process evaluations and validations. Lead investigator/author for multiple quality investigations, CAPA and deviations.

Responsible for the day to day Drug Substance and Drug Product manufacturing for XBiotech's True Human monoclonal antibodies used for multiple clinical trials. Lead a team of 15+ scientists and associates across two different cGMP facilities. Oversaw all Process Development efforts within XBiotech's antibody collection. Designed the manufacturing process, upstream and downstream, for three different cell lines. Designed the SOP for and manufactured multiple master and working cell banks. Lead negotiations with CMOs for off-site manufacturing activities. Lead author on all CMC related documents pertaining to manufacturing or process development activities. Routinely authored SOPs, Production Records and Test Plans. Lead investigator on multiple quality investigations, deviations and CAPAs.

Lead downstream manufacturing Process Development scientist. Designed and implemented a new downstream purification process which increased product quality attributes and overall yield. Developed XBiotech's subcutaneous drug delivery platform as well as additional formulations. Identified novel targets for XBiotech's lead molecule. Expressed and purified antigens used as targets for novel antibodies for both in vivo and in vitro experimentation.

Killeen/Temple, Texas Area

Developed novel purification schemes for several biologics used for Phase I studies. Set up a bacterial cGMP facility and maintained the fermentation facility within. Lead scientist for expression and purification of biologics within cGMP facility.

Doctor Of Philosophy (Ph.D.), Cell/Cellular And Molecular Biology/Biochemistry

Bachelor Of Science (Bs), Biology, General