2021 -2022 CMC Strategy Director in Global Quality, AstraZeneca Biologics @
2018 -2021 Head of Product Quality Group at AstraZeneca Biologics @ AstraZeneca Biologics
2016 -2018 Director of Corporate Quality @ AstraZeneca Biologics
2014 -2016 Director of QA Technology @
2009 -2014 Principal Scientist (Associate Director) @
2007 -2009 Director of Quality Control @ Favrille, Inc.
2001 -2007 Manager of QA Technical Services and Compendial Liaison @
1998 -2001 Principal Scientist @
Stephan Krause Education
University of Southern California
PhD (Analytical Chemistry, Biochemistry,)
1993-1998
Stephan Krause Skills
Assay Development
V&V
Technical Support
CMC
FDA
21 CFR Part 11
GxP
Change Control
Biologics
Corrective and Preventive Action Capa
Pharmaceutical Industry
CAPA
Validation
Project Management
Quality System
u.s. Food and Drug Administration Fda
Technology Transfer
Services
Vaccines
Biopharmaceuticals
Regulatory Requirements
C++
Standard Operating Procedure Sop
Sop
Analytical Chemistry
Research
Quality Assurance
Negotiation
Regulatory Submissions
Statistics
Biotechnology
Analytical Skills
Regulatory Affairs
Design of Experiments
Support
Liaison
Public Speaking
Standard Operating Procedure
u.s. Food and Drug Administration
Corrective and Preventive Action
Stephan Krause Summary
Stephan Krause, based in Gaithersburg, MD, US, is currently a Executive Director, Analytical Science and Technology, Cell Therapy Quality, Bristol Myers Squibb at Bristol Myers Squibb. Stephan Krause brings experience from previous roles at AstraZeneca and AstraZeneca Biologics. Stephan Krause holds a 1993 - 1998 PhD in Analytical Chemistry, Biochemistry, @ University of Southern California. With a robust skill set that includes Assay Development, V&V, Technical Support, CMC, FDA and more. Stephan Krause has 3 emails and 3 mobile phone numbers on RocketReach.
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