Paul e Aboody

About Paul e Aboody

QUALIFICATION HIGHLIGHTSMotivated and results-focused manager with more than 29 years of experience spearheading complex sterile manufacturing, operations, and training projects. A skilled veteran of process improvement with a record of establishing effective manufacturing procedures that have increased the quality of deliverables. Recruit diverse, highly skilled teams of quality systems experts to evaluate, identify shortfalls, and develop comprehensive solutions proven to achieve success and meet FDA, EMEA, and HPFBI regulations. Consistently increase the effectiveness of staff by executing performance reviews and developing personalized professional development plans. Accurately evaluate the quality of sterile manufacturing processes, operations, and the manufacturing of drug substances and products- Aseptic Process Sterile Study (APSS)- Sterile Process (APA)- Media Fill / Interventions / RABs / Isolators - Vaccine- Antibiotics- Solid Oral Dosage- 503A/503B- Smoke Studies- Process Design- CAPAs, Deviations, NCR Review and Approving (MRB)- Auditing (internal and CMOs p1, p2, and p3)- Batch Record Review- Product Release- Compounding - Purification - WFI and RO/DI system- Buffer Stability Studies - Lyophilzation- CIP/SIP Tanks/Reactors Validation studies- Room Classification and pressurization (ISO)- Dirty and Clean Hold Studies- Packaging Final Packaging and Labeling- EMEA, 21CFR 210, 211, 795, 797- VMP - New cGMP Facility Start up- Process and equipment validations (Reactors “Spray ball Coverage”, Autoclaves, Ovens, Lyophilizers)- Establishing a QAD (Quality Assurance Documentation) group and archiving system- Software (Smart Solve, Track Wise, Documentum, Masters, SAP)

Experience

1. Head of Operations

   Alvotech

   Jul 2025 — Present · Reykjavik, IS

Education

• Quinsigamond Community College

  Biotechnology

  1995 — 1999

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Software Documentation
• Root Cause Analysis
• Change Control
• Validation
• Regulatory Requirements
• Lims
• Biotechnology
• Quality Control
• Gmp
• Cross-Functional Team Leadership
• Vaccines
• Retention Strategies
• U.s. Food and Drug Administration (Fda)
• Contract Manufacturing
• Corrective and Preventive Action (Capa)
• 21 Cfr Part 11
• Quality Assurance
• Aseptic Technique
• Quality System
• V&V
• Design Control
• Program Management
• Project Management
• U.s. Title 21 Cfr Part 11 Regulation
• Glp
• Verification and Validation (V&V)
• Computer System Validation
• Manufacturing
• Medical Devices
• Capa
• Technology Transfer
• Management Consulting
• Manufacturing Operations
• Gamp
• Biopharmaceuticals
• Regulatory Affairs
• Lifesciences