Vice President, Quality Operations and Regulatory Affairs @ (September 2010 - January 2012)
Director, Manufacturing Quality Assurance @ DSM Pharmaceuticals, Inc. (September 2008 - October 2010)
Manager and Director, Sterile Manufacturing Quality Assurance @ DSM Pharmaceuticals, Inc. (March 2006 - September 2008)
Manager, Oral Solid Dose Quality Assurance @ DSM Pharmaceuticals, Inc. (April 2003 - March 2006)
Sr. Group Leader, Sterile Quality Assurance @ DSM Pharmaceuticals, Inc. (April 2002 - April 2003)
Validation Group Leader @ (October 1998 - April 2002)
Analytical Research Chemist @ (April 1996 - October 1998)
Shane Ernst Education
Purdue University
Bachelor of Science (B.S.) (Biochemical Engineering; Biochemistry)
1990-1995
Shane Ernst Skills
Quality Assurance
Validation
GMP
Regulatory Affairs
FDA
CAPA
Pharmaceutical Industry
Quality System
Change Control
Leadership
21 CFR Part 11
Technology Transfer
SOP
Manufacturing
Biopharmaceuticals
Six Sigma
Deviation Management
Aseptic Processing
GLP
Customer Support
21 CFR
GxP
Medical Devices
Quality Control
Remediation
Cross-functional Team Leadership
Continuous Improvement
Quality Auditing
LIMS
Computer System Validation
Process Improvement
V
Management
Biotechnology
Pharmaceutics
Corrective and Preventive Action Capa
Standard Operating Procedure Sop
Cross Functional Team Leadership
Cross Functional Team
Computer System
Public Speaking
Testing
Marketing
Business Process Improvement
u.s. Food and Drug Administration Fda
Standard Operating Procedure
u.s. Food and Drug Administration
Corrective and Preventive Action
Shane Ernst Summary
Shane Ernst, based in Greenville, NC, US, is currently a Vice President Quality Assurance and Quality Control at Palvella Therapeutics. Shane Ernst brings experience from previous roles at Empower Pharmacy, Aimmune Therapeutics, Glenmark Pharmaceuticals and Pfizer. Shane Ernst holds a 1990 - 1995 Bachelor of Science (B.S.) in Biochemical Engineering; Biochemistry @ Purdue University. With a robust skill set that includes Quality Assurance, Validation, GMP, Regulatory Affairs, FDA and more. Shane Ernst has 3 emails and 2 mobile phone numbers on RocketReach.
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