Quality Management - Drug Product Quality and Escalation Management @ (October 2019 - July 2023)
Director, Manufacturing Quality Assurance @ (August 2017 - July 2019)
Director, GMP Compliance and Quality Operations @ Endo Pharmaceuticals (October 2015 - August 2017)
Manager QA Compliance and GMP Compliance Auditor @ Endo Pharmaceuticals (November 2011 - September 2015)
Senior Quality Assurance Specialist @ (July 2007 - November 2011)
QA Compliance Liaison @ (August 2005 - July 2007)
Manufacturing and Quality Assurance @ (January 1995 - January 2005)
QAV Change Control Specialist @ (September 2004 - December 2004)
R and D QA and Site QA Lead Investigator III @ (October 2002 - September 2004)
QA Procedures Unit Supervisor @ (June 2001 - October 2002)
QA Procedures Unit Analyst @ (January 2001 - May 2001)
Supervisor @ (June 1997 - January 2001)
Biological Manufacturing Technician @ (January 1995 - May 1997)
Christian Schell Education
Temple University 2007-2009
Lock Haven University 1994
Christian Schell Skills
GMP
CAPA
Change Control
Validation
FDA
Pharmaceutical Industry
Computer System Validation
Quality System
Quality Assurance
Biotechnology
SOP
GxP
GLP
21 CFR Part 11
Biopharmaceuticals
Quality Control
Quality Auditing
Aseptic Processing
Vaccines
Clinical Trials
Drug Development
TrackWise
External Audit
Internal Audit
Regulatory Requirements
Sterilization
GCP
Clinical Development
ISO 13485
Aseptic Technique
21 CFR
ICH Guidelines
Corrective and Preventive Action (CAPA)
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
Good Clinical Practice (GCP)
Root Cause Analysis
Team Leadership
Lean Manufacturing
Quality Management
Continuous Improvement
Cross-functional Team Leadership
Manufacturing
Supplier Quality
Supplier Quality Management
Lyophilization
Event Management
Complaint Investigations
Supplier Evaluation
Kaizen
Accounting
Business Analysis
Microsoft Office
Customer Service
Financial Analysis
u.s. Food and Drug Administration Fda
Sales
Strategic Planning
Training
Standard Operating Procedure Sop
Corrective and Preventive Action Capa
Good Clinical Practice Gcp
Cross Functional Team Leadership
Standard Operating Procedure
u.s. Food and Drug Administration
Good Clinical Practice
Corrective and Preventive Action
Christian Schell Summary
Christian Schell, based in Harrisburg, NC, US, is currently a Senior Director, GMP Quality Assurance at Asklepios BioPharmaceutical, Inc. (AskBio). Christian Schell brings experience from previous roles at Esperion - The Lipid Management Company, Glenmark Pharmaceuticals and Endo Pharmaceuticals. Christian Schell holds a 2007 - 2009 Temple University. With a robust skill set that includes GMP, CAPA, Change Control, Validation, FDA and more. Christian Schell has 3 emails and 3 mobile phone numbers on RocketReach.
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