Les D. Mintzmyer
Senior Biologics Manufacturing Consultant
Mr. Mintzmyer is our hands-on expert for managing and directing biologics contract manufacturing organizations (CMO). He has led the commercial manufacturing operations for a multi-product facility directing materials management, inoculum, cell culture, purification, facilities, engineering and strategic support.
He successfully prepared a full service 6x20kL biologics facility for an FDA PAI, ultimately receiving biologic product manufacturing approval. The Operation grew from 60 to over 225+ employees in under 2 years.
His Consultant experience includes:
- Technical interface with Contract Manufacturing Organizations assisting in their preparation of proposals for consideration as a second manufacturing site for a client product
- Provided process knowledge input and experimental design guidance for obtaining data leading to process improvements and manufacturing robustness securing drug product supply to market
- Collaborated with client’s internal team to bring a new product and technology to manufacturing site
Prior to joining DSI, Mr. Mintzmyer served as Vice President, Manufacturing Operations for Jazz and Celetor Pharmaceuticals. Additionally, he served in a VP role for two CMOs; Avid Bioservices and Laureate Biopharmaceutical Services.
- Executive Leadership
- Biologic Manufacturing
- CMO Management
- Liposome Development
- Tech Transfer
- Supply Chain
- FDA PAI
- Process Improvement
- Upstream Manufacturing