2010 -2015 Validation Project Manager and Owner's Representative @
2009 -2010 Project Management Support, Commissioning and Qualification @
2007 -2008 Commissioning and Qualification Manager @
2006 -2006 Project Manager @ Eli Lilly
1998 -2006 SE Regional Director, Compliance @ IPS
1998 -2005 SE Regional Director, Compliance @ Integrated Project Services
2003 -2004 Project Director, Commissioning and Qualification @ Eli Lilly
2000 -2000 Validation Specialist @
1998 -1999 Validation Project Leader @ Centocor
1996 -1998 Project Leader @
Thomas McCullough Education
Marywood University
Bachelor of Science (BS) (Biology)
1990-1993
Thomas McCullough Skills
Medical Devices
Quality Auditing
Technology Transfer
Software Documentation
Scheduling
Aseptic Processing
Budgeting
CAPA
Pharmaceutics
R&d
Regulatory Affairs
Planning
Computer System
Quality Control
Pharmaceutical Industry
Preparation
Budgets
GLP
GMP
Cleaning Validation
Process Simulation
V&V
Biotechnology
Lifesciences
Quality Management
21 CFR Part 11
FDA
Engineering
Quality System
Change Control
Process Scheduler
Clinical Trials
GxP
Document Management
Project Planning
New Business Development
Business Development
Coordination
Data Management
ISO 13485
Commissioning
Project Management
Biopharmaceuticals
Validation
Supervisor
Sop
Quality Assurance
cGMP
Microbiology
Process Validation
Computer System Validation
Manufacturing
Automation
Marketing
Urs
Writing
Substance
Logic
Chemical
Corrective Actions
Master Plan
Clinical Manufacturing
Vendors
Community
Loop
National Honor Society
Project Metrics
Performance Metrics
Cycles
Data Mapping
Physical Properties
Pharmaceutical Product Development
Utilities
Utility Systems
Design Review
Construction
Batch Processing
SME
Dynamics
Document Preparation
ANDA
Technical Data
Technical Services
Management
Loading
Delta
Design
Equipment Operation
Owner'S Representative
Contractors
Cfr
Resume
Auditing
Workflow
Parenteral
Human Resources
Execution
Process Automation
Oracle Application Express
Qualification
Philadelphia
Guidance
Forecasting
Customer Satisfaction
System
Business Services
Project Tracking
Project Leadership
Tests
Navigation
Reports
Asset Allocation
County
Reporting Metrics
Supervision
Inventory
Insulin
Aseptic Technique
Facilities Operations
PV
Compounding
Testing
Piloting
Asset Management
Reporting Tool
Training
Technical Reports
Fast Track
Documentation
Research
Product Development
Conflict Resolution
Mitigation
Reporting
Capital
Investigation
Information Management
Analysis
Wax
Drawing
Inspection
Home Staging
Steam
Solutions Marketing
Sterilization
Systems Design
Antibacterial
Validation Master Plans
Catholicism
CIP
C
RFP
Comprehensive Planning
Operations Experience
Buffer
Production Support
FIX Protocol
Prince
Ispe
Business Expansion
Communication
Schedules
Staff Augmentation
Detail
European Union
ERP
Development Studies
User Requirements
SIP
Regulatory Requirements
Operations
Metric Reporting
Renovation
Filtration
Checks
Capsules
Balancing
Production Schedules
Remediation
Project
Lyophilizers
Facilities Management
Business Process Mapping
Centrifugation
Batch Records
Utility
Dentistry
Responsibility
Six Sigma
Therapists
Packaging
Injection Molding
Regulations
Project Teams
International
Business Units
Biology
Report Writing
Start Ups
Forms
HVAC
Colleges
Fractionation
Unloading
Control Systems Design
Bridge Inspection
Patient Outcomes
Bulk
Compliance
Factory
Work Instructions
Program Management
Internal Controls
Stability
Contingency
Formulation
Precipitation
Pre Approval
Calibration
Delivery
Nitrogen
Lyophilization
Coordinated
Thomas McCullough Summary
Thomas McCullough, based in Raleigh, NC, US, is currently a President at CORE, a Unicon Company. Thomas McCullough brings experience from previous roles at Core Service Group, Inc., Grifols, Eisai and MannKind Corporation. Thomas McCullough holds a 1990 - 1993 Bachelor of Science (BS) in Biology @ Marywood University. With a robust skill set that includes Medical Devices, Quality Auditing, Technology Transfer, Software Documentation, Scheduling and more. Thomas McCullough has 4 emails and 1 mobile phone numbers on RocketReach.
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