2023 -2026 Vice President, Clinical Manufacturing Site Head @
2021 -2023 Executive Director, Clinical Site Head @
2018 -2021 Sr. Director, Technical Operations and Engineering @ AveXis, Inc.
2016 -2018 Director of Engineering and Validation @ AveXis, Inc.
2012 -2016 Sr. Project Manager @
2005 -2012 Senior Engineer @
2004 -2005 Office Manager @
1999 -2003 Senior Automation Engineer @ Process Analysts Inc.
1995 -1999 Automation Engineer @
Scott Bertch Education
Drexel University
BS (Electrical engineering)
1990-1995
Scott Bertch Skills
Automation
Validation
Commissioning
GMP
Change Control
FDA
Project Management
21 CFR Part 11
Computer System Validation
Biotechnology
Process Improvement
PLC
GAMP
Instrumentation
Quality System
Process Engineering
Process Automation
Electrical Engineering
Manufacturing
Team Leadership
Pharmaceutical Industry
DCS
Process Simulation
Technology Transfer
SCADA
Process Control
Cross-functional Team Leadership
Six Sigma
Sop
Allen Bradley
V&V
Root Cause Analysis
Process Optimization
Control Logic
MES
GLP
GxP
LIMS
Medical Devices
Software Documentation
Calibration
Quality Control
Project Engineering
Lean Manufacturing
ISO 13485
Chromatography
R&D
FMEA
Design Control
Leadership
Strategy
Testing
Cross Functional Team Leadership
Project Planning
Management
Financial Analysis
Sales
Customer Service
Scott Bertch Summary
Scott Bertch, based in Pleasanton, CA, US, is currently a Chief Operating Officer at cGMPnow. Scott Bertch brings experience from previous roles at Tenaya Therapeutics and AveXis, Inc.. Scott Bertch holds a 1990 - 1995 BS in Electrical engineering @ Drexel University. With a robust skill set that includes Automation, Validation, Commissioning, GMP, Change Control and more. Scott Bertch has 2 emails and 2 mobile phone numbers on RocketReach.
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