Thageron Allen

About Thageron Allen

As a pharmaceutical professional who has worked in Operations and through interaction within collaborative teams, has recognized the desperate need for systemic LEAN approaches to all facets and work flows in the pharmaceutical industry. I build productive teams and push for smart investment and optimization of technologies that will increase business operation productivity and return on investment, without compromise to quality. My ability to influence and manage change makes me a powerful addition for companies looking for leaders of innovation. • Manager with extensive experience in manufacturing operations for large pharmaceutical companies who has converted over to teaching others the indelible art of quality leadership. • Effective in new product development/manufacturing, technical training, and operational management. • Validation Engineer who has performed computerized system, equipment, instruments, method, and process validation for whole life cycle of products, equipment, and environments in regulated industry.AREAS OF EXPERTISEQUALITY SYSTEMS, OPERATIONS & COMPLIANCE Process Optimization GMP/GLP Compliance, Design Controls & Validations IT & Quality Systems Integration Operational Excellence & Lean Manufacturing Cybersecurity & Data GovernanceLEADERSHIP, CULTURE & GROWTH Leading High-Performing Interdisciplinary Teams Employee & Customer Engagement Training, Development & Restructuring Cultural & Operational Transformation Supplier Quality & Vendor ManagementWHAT I DELIVER Leading and scaling Validation departments incorporating calibration, facility and vendor management for effective operational support Partnering in authorship and corrections to FDA 483s, warning letters, and audit risks Shaping global regulatory frameworks through extensive operational and quality application of current industry techniques and effective validation demonstration through test and requirement fulfillment Aligning Preventive maintenance, Operations, and Quality Assurance elements for continuous compliant manufacture of products to meet patient specifications using calibrated and validated equipment and processes

Experience

1. Independent Contractor Consultant

   PharmaLex

   Feb 2025 — Present · Carlsbad, CA, US

   Leading commissioning and qualification effort for multiproduct global nutrition and supplement company. Elements of the project involve equipment validation (depyrogenation ovens, tablet press, packaging line, and metal detectors), cleaning validation, and environmental monitoring qualification within 10-month timespan.

Education

• University of California, Berkeley

  BA, Political Science

Skills

• U.s. Title 21 Cfr Part 11 Regulation
• Manufacturing
• Standard Operating Procedure (Sop)
• Quality Assurance
• Change Control
• Corrective and Preventive Action (Capa)
• Cross-Functional Team Leadership
• Biotechnology
• Protein Purification
• Software Documentation
• Lean Manufacturing
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• 21 Cfr Part 11
• Capa
• Recombinant Dna Technology
• Quality Control
• Gmp
• Biopharmaceuticals
• Quality System
• V&V