George Khoury
Novartis, Milburn, NJ, Amgen NC and Celularity, Florham Park, NJ
East Hanover,NJ
1
Certification
26
years of professional experience
Results-oriented leader with 24 years of experience in Quality, Compliance, Engineering, and Validation within advanced therapy and biopharmaceutical sectors. Drives a patient-focused team culture and leads cross-functional teams to achieve strategic goals. Skilled in communication, analytical thinking, and problem-solving to deliver high-quality results.
Work History
Consultant and Subject Matter Expert CQV, CSV, Investigation, Remediation and automation programming
3 Years 11 Months- CQV lead SME for qualification and validation activities.
- Managed remediation of health authority response and new expansion projects, coordinating deliverables across cross-functional departments with 20 direct reports and providing weekly updates to site SLT team.
- Led the commissioning, qualification, and validation process as a subject matter expert. for qualification and validation activities.
- Developed User Requirements Specification (URS), Scope of Facility (SOF), Basis of Design (BOD), and Requests for Proposal (RFP) for corporate project teams and vendors during project walk-throughs in production, warehouse, and lab areas.
- Managed construction projects as a subject matter expert for clean and dirty utilities. clean and dirty utilities such as Electrical, HVAC, Clean Room, WFI / RO (Reverse Osmosis and DI utilities and etc.
- Construction Manager/SME for clean and dirty utilities such as electrical, HVAC, clean room, WFI / RO (Reverse Osmosis and DI utilities and etc.
- Revised QMS processes and procedures to enhance repeatability and sustainability in the deviation process for Celularity, remediating legacy QMS investigations based on audit findings.
Sr. Manager: CTDO, Reliability, GMP Facilities, Compliance, Continuous Improvement
2 Years 10 Months- Lead SME across large scale capital projects, global procedures, and 7 external audits for cell therapy manufacturing.
- Managed audit responses for GMP clean room design, personnel & material flows, biosafety cabinet certifications, building automation systems, process equipment, calibration & maintenance programs, CMMS system, and pest control, ensuring compliance with FDA, EMA, Health Canada, and Japan PMDA regulations.
- Developed 3–5-year plan across CTDO (cell therapy development and operations) departments comprised of capital management for facility & process equipment, operational reliability, GMP engineering and cleaning operations.
- Audit response lead for engineering and facilities across FDA, EMA, Health Canada, Japan PMDA regulations in support of commercial approval of cell therapies Breyanzi and Abecma for production, warehouse and lab(s)areas.
- Developed a comprehensive 3–5-year capital management plan for CTDO departments focusing on facility & process equipment, operational reliability, GMP engineering, and cleaning operations to enhance operational efficiency.
- Led high performing teams across the CTDO departments with a focus on quality results and fostering a patient focused culture enabling department growth and delivery across the business units.
- Oversaw 9 direct and 38 indirect reports, ensuring effective collaboration among internal and external team members.
- Fostered a collaborative team environment by creating growth & development opportunities aligned with individual, departmental, and company goals, contributing to high team retention.
Sr. Product Manager/ Project Manager
1 Year 4 Months- Global Product Manager for medical devices for revenue protection projects.
- Identified project scope, presented to stakeholders, documented plan, executed and led through close out of projects (E2E).
- Managed project using AdaptiV, MS Project, and MS OneNote to streamline workflows.
- Led global efforts for developing standardization for URS to IOQ.
Sr. Project Manager/Sr. GMP Engineer
1 Year 8 Months- Managed installation of new construction, process equipment, clean utilities, aseptic filling, and packaging, ensuring compliance through qualifications and training.
- Developed, reviewed, and approved Environmental Health and Safety (EH&S), HAZard and OPerability analysis (HAZOP) for a facility upgrade project exceeding $65 Million (MM).
- Led EH&S and savings project for facility improvements. by installation of Methanol Virgin and Waste tank project. Presented to leadership group as a ROI capital project. Prior usage was handled with totes.
- Subject Matter Expert (SME) for cGMP clean utilities.
- Acted as SME for 483 responses on compliance issues. for all manufacturing equipment, building integrity and utilities.
- Reviewed and approved IOV, IOQ, CD, PQ for fractionation tanks, sharples, filter presses, drum filter, bottle cutter, air handlers, production rooms, fillers, inspection machines, and packaging equipment.
- Ensured compliance (TrackWise) with Change Controls, Corrective Action (CAPAs) and Deviations. Direct oversight of 6 contract firms for a duration of two years.
Corporate Project Manager
3 Years 4 Months- Corporate Project Manager for United States Northeast, China and Canada locations (19 locations, 60%+ travel).
- Oversaw technical aspects of projects, ensuring compliance with electrical, mechanical, automation, piping standards.
- Directed medium and large-scale capital projects from initial business case through design and implementation, establishing team roles and responsibilities while leading up to 15 members to meet scope, schedule, and budget targets. Provided biweekly updates to leadership.
- Led the project management for building consolidation through the New York and New Jersey plants.
- Assessed client design change requests for process modifications and presented business cases for approval.
Independent Consultant: GMP Capital Project Manager, Sr. Project Engineer, Validation Engineer, Construction Manager and Quality Engineer
8 Years 6 Months- Cross-functional Project Manager working with various clients in the biotech space. Manage scope, schedule and budget. Developed communication plans and strategies, provided/presented updates to leadership, and managed internal staff and vendor relationships.
- Various project design projects as the project manager, engineering and validation lead. Led projects thru design gates, construction, and qualification.
- Experience managing and developing validation strategies and plans. Develop Commissioning, Installation Operation Verification (IOV), Installation Operation Qualification (IOQ), Cycle Development (CD), Performance Qualification (PQ) and Performance Verification (PV) protocols.
- Managed and developed User Requirements Specification (URS), Scope of Facility (SOF), Basis of Design (BOD), Options Analysis Report (OAR), and Requests for Proposal (RFP) for corporate project teams and vendors during project walk-throughs.
- Managed and developed validation strategies and plans, creating Commissioning, Installation Operation Verification (IOV), Installation Operation Qualification (IOQ), Cycle Development (CD), Performance Qualification (PQ), and Performance Verification (PV) protocols.
- Conducted smoke study aseptic dynamic testing to qualify rooms, biological safety cabinets, and HEPA carts.
- Led multiple projects to enhance operational efficiency in biotech. as the SME for HVAC, control wiring, electrical, and building automation within the biotech space.
- SME for procurement thru qualification of commercial off the shelf of cGMP systems including but not limited to: incubators, BSCs, centrifuges, TFF skids, chromatography skids etc.
Combat War Marine
4 Years- Developed and updated SOPs for Marine Corps operations, enhancing operational efficiency.
- Worked as a Marine Corps translator, combat cook, and embarkation representative.
- Led safety training for equipment and hazardous materials while instructing in the Middle East, completing 5 tours in Iraq over 2.5 years.
Education
B.S. - Industrial Engineering
GPA: 3.7
Skills
ISO-14644 standards
ISO5000 and ISO5001
FMEA
Hazop
21CFR part11
FDA 483 responses CME 30 submittals
EudraLex and ANNEX
ASTM E2500
Lean methodologies
Building automation
BMS and PLC systems
RSLogix 5/RSLogix 5000 & iFix Intellution
Steam Sterilization
Optimization/ process improvement
Process validation
Process optimization
Quality assurance
Quality control
Document control
Packaging equipment
Fillers with Piston
peristaltic and rotary pumps
Vial and Syringe filling Machines
Vial Washers
Inspection machines
Labeler Machines
Bosch tray formers
Bosch pick and place machines
LT Columbia palletizers
Fitzpatrick Compactor Machines
TeledoXray
Vision Inspection IP Genius System
Steris CIP systems
Hot Air Ovens
Scan Hepa Carts
MS Excel professional
MS Office
SharePoint
Data analytics
Performance tracking
Operations analysis
Project management
Project leadership
Project implementation
Project analysis
Change management
Work Planning and Prioritization
Strategic planning
Forecasting
Forecasting techniques
Business analysis
Business planning
Continuous improvement
Cross-functional collaboration
Client management
Team leadership & development
Team mentoring
Client engagement
Client engagement
Stakeholder engagement
Client assessments
Executive support
Integrity and honesty
Problem-solving
Analytical thinking
Attention to detail
Issue resolution
Goal setting
Timeline development
Assessments
Performance evaluation
Resource evaluation
Lifecycle management
Best practices
Organizational design
Process management
Process enhancement
Employee management
Time management
Safety regulations
Project analysis
Subject matter expert
Safety regulations
Client assessments
Executive support
Assessments
Performance evaluation
Requirements gathering
Lifecycle management
Quality control
Resource evaluation
Document control
Certification
Six Sigma Yellow Belt (2021) GIA Diamond Expert (2013), GIA Appraisal (2012), CPR and First Aid (2012) U.S. Marine Corps Certifications: Culinary Arts Degree, Combat Marshal Arts (Gray & Tan Belt), Embarkation Represented to ship Hazard Material Overseas, Nutritionist Trainer
Knowledge Areas
- Program Management
- Team Leadership
- Mid to Large Capital Budget
- Sterile Room Design thru media qualification
- Develop MSA and RFP agreements
- Architectural, P&IDs, Mechanical, Electrical and Zoning drawings
- Automation Validation
- Packaging equipment
- Centerline Equipment
- Change controls/Trackwise, Lockout/Tagout and Confined Manufacturing
- Industrial Engineering (6 sigma, forecasting, process and quality)
- Return on Investment
- Commissioning and Qualification Environmental Health and Safety
- Process Improvement
- Logistics & Quality Control
- Non-Conformances & CAPAs
- Annex 1
- 21CFR Part 210, 211
- Problem Solver & Troubleshooter
- Failure Mode and Effective Analysis
Timeline
Consultant and Subject Matter Expert CQV, CSV, Investigation, Remediation and automation programming
Novartis, Milburn, NJ, Amgen NC and Celularity, Florham Park, NJ
08.2022 - CurrentRead More
Sr. Manager: CTDO, Reliability, GMP Facilities, Compliance, Continuous Improvement
Celgene/BMS
09.2019 - 07.2022Read More
Sr. Product Manager/ Project Manager
Contractor Johnson and Johnson (Ethicon)
07.2018 - 11.2019Read More
Sr. Project Manager/Sr. GMP Engineer
Kedrion Bio Pharmaceuticals USA
11.2016 - 07.2018Read More
Corporate Project Manager
NBTY (NATURE BOUNTY Nutraceuticals)
07.2013 - 11.2016Read More
Independent Consultant: GMP Capital Project Manager, Sr. Project Engineer, Validation Engineer, Construction Manager and Quality Engineer
Amgen, Ben Venue Laboratory, Boehringer Ingelheim, Stantec, Novartis Sandoz, & Confidential Clients
01.2005 - 07.2013Read More
Combat War Marine
United States Marine Corps
12.2000 - 12.2004Read More
University of Illinois at Chicago
B.S. from Industrial Engineering
Read More