Ulrich Ernst

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.

Country

United States

City

Pleasanton

Industry

Biotechnology

Skill

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

20Crowley LLC BioConsulting

Executive Leader and Product Developer | Connecting entrepreneurs with investors

20Crowley LLC BioConsulting

2026-2 - Present · 8 mos
ProKidney Corp.

Executive Vice President Technical Operations

ProKidney Corp.

LinkedIn
2024-3 - Present · 2 yrs 7 mos
Iovance Biotherapeutics, Inc.

SVP Technical Operations

Iovance Biotherapeutics, Inc.

LinkedIn
2019-5 - 2024-2 · 4 yrs 10 mos

San Carlos, CA

AMTAGVI approved.

Amunix

SVP Technical Operations/COO

Amunix

2015 - 2019 · 4 yrs

Mountain View, CA

Amunix

Sr. VP Manufacturing and Quality Operations

Amunix

2013 - 2015 · 2 yrs
Cytovance Biologics

Sr. Vice President Manufacturing Operations

Cytovance Biologics

LinkedIn
2011 - 2012 · 1 yr
Alexion Pharmaceuticals, Inc.

Vice President Manufacturing/Head of ARIMF

Alexion Pharmaceuticals, Inc.

LinkedIn
2009 - 2011 · 2 yrs

Smithfield, RI

ZymoGenetics Inc.

Vice President Manufacturing

ZymoGenetics Inc.

2006 - 2009 · 3 yrs
Scios (JNJ) Inc.

Director Manufacturing Operations

Scios (JNJ) Inc.

2004 - 2006 · 2 yrs
Baxter BioScience

Sr. Manager Manufacturing

Baxter BioScience

1995 - 2004 · 9 yrs
Baxter

Sr Manager

Baxter

1995 - 2004 · 9 yrs

Education

Lehigh University

Lehigh University

LinkedIn

Chemical Engineering

Ulrich Ernst's Contact Information

Email

******@***.com

Phone

(**) *** ****

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