Ulrich Ernst
Executive Leader and Product Developer | Connecting entrepreneurs with investors
About
Entrepreneurial, results oriented leader in cell and gene therapy and biopharmaceuticals (process development, manufacturing, CMC, facility, quality and supply chain operations). Successful track record of bringing complex process operations through to commercialization and establishing cost-effective organizational structures. Multiple successes (4 biologics SOLIRIS, ADVATE, RECOTHROM; NATRECOR; 1 cell therapy - AMTAGVI) in gaining new product marketing authorizations and manufacturing facilities approvals. Key organizational leadership roles and broad scope of responsibility with multinational and development-stage firms covering P&L, business development, in-house/contract manufacturing, process development, quality, technology transfer, engineering, supply chain and global/US regulatory CMC.
United States
Pleasanton
Biotechnology
Regulatory Interactions, Monoclonal Antibodies, Quality Assurance, Manufacturing Operations, Regulatory Affairs, Continuous Improvement, Manufacturing Operations Management, Quality Management, Drug Development, Biochemistry, Gene Therapy, Process Development, Manufacturing, Biotechnology, Biopharmaceuticals, Technology Transfer, GMP, FDA, Validation, CAPA
Experience

Executive Leader and Product Developer | Connecting entrepreneurs with investors
20Crowley LLC BioConsulting

SVP Technical Operations/COO
Amunix
Mountain View, CA

Sr. VP Manufacturing and Quality Operations
Amunix

Vice President Manufacturing
ZymoGenetics Inc.

Director Manufacturing Operations
Scios (JNJ) Inc.

Sr. Manager Manufacturing
Baxter BioScience

Sr Manager
Baxter
Ulrich Ernst's Contact Information
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