30 years in biopharma with broad expertise across multiple biologic modalities including AAVs, recombinant proteins, vaccines, plasmid DNA, and antibodies
CMC
Regulatory
Business Analytics
Quality & Compliance
Joe comes to Dark Horse after 30 years in the biopharmaceutical industry with both large pharma and startup biotech companies. He has broad expertise across multiple biologic modalities including AAVs, recombinant proteins, vaccines, plasmid DNA, and antibodies.
For the past several years, Joe’s primary focus has been with process development and manufacturing of AAV derived gene therapy products. He has held multiple roles across process development, MSAT, and manufacturing at startup gene therapy companies at stages from pre-clinical through commercial operations. Joe’s main contribution to these organizations has been the establishment of robust, scalable, and well-controlled manufacturing processes.
During his time at AveXis, Joe held roles in process development, MSAT and manufacturing as the company matured into commercial operations. Joe was a key contributor to the BLA CMC efforts for Zolgensma® including the development of the upstream process, process validation, and ownership of several module 3 sections. Joe later led the manufacturing team at the AveXis core facility in North Carolina, which manufactures both clinical and commercial AAV products from conceptual design through global regulatory approvals.
While at Jaguar Gene Therapy, Joe led the development efforts for a novel suspension AAV manufacturing process through 500-liter scale. This process allowed for the manufacture of several wtAAVs as well as engineered AAV capsids. This process has industry leading yield, purity, and cost of goods.
At Advanced Medicine Partners, Joe led the R&D and MSAT team for a newly formed boutique CDMO focused on AAV and LVV products. Joe was able to solve several manufacturing challenges associated with novel AAV capsids and enabled clients to advance their programs to the IND stage with minimal time and expense.
Outside of work, Joe enjoys fishing, hiking, and experiencing new locations and people with his family.
At AveXis Joe developed the upstream manufacturing process and served as the process owner for three internal and one external manufacturing site through the facility startups and BLA approval. Joe was a lead inventor for the Zolgensma® manufacturing patent.
