2002 -2003 Sr. Group Leader, Sterile Quality Assurance @ DSM Pharmaceuticals, Inc.
1998 -2002 Validation Group Leader @
1996 -1998 Analytical Research Chemist @
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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