Luis V. Feliciano

About Luis V. Feliciano

Assertive, creative, results-driven leader with extensive experience in manufacturing operations management, pharmaceutical technology and validation with several major solid oral dosage pharmaceutical companies. Experienced in:• Strategic business plan development and execution• Budget management, P&L statements• Operations management under diverse industry regulations (cGMP, OSHA, DEA, and others)• Leading cross-functional teams• Interfacing with FDA, MHRA and other agencies in regulatory inspections• Remediation plan implementation• Quality by Design• Lean / Six Sigma• Management of third party resources in the US and Europe, requiring up to 40% travelDemonstrated ability to analyze and identify root causes to quickly develop optimal solutions. Team building, change and continuous improvement agent. Computer literate (MS Word, Excel, PowerPoint, Outlook). Proficient in English & Spanish (oral and written).Key Accomplishments:• Completed process development and manufacturing of drug product registration batches for new product in clinical studies (20••••12, Reata).• Directly executed 2 product technology transfer projects to new facilities (20••••11, Cephalon).• Led team in equipment / utilities qualification and start up of state of the art manufacturing module for new product launched in 2008. This module featured electronic batch record, process analytical technology (PAT) and high automation integration levels (20••••08, Wyeth).• Led team in execution of technology transfer projects leading to filing of 6 new products in 2 years (Watson).• Key contributor to execution of work plan as part of consent decree with FDA (20••••03, Schering).• Established Validation Department with responsibility for Process Validation, Cleaning Validation, Equipment Qualification, and Computer Validation. Completed validation of over 80 products in 4 years (Abbott).

Experience

1. Site General Manager

   Teva Pharmaceuticals

   Mar 2019 — Present · Fairfield, NJ, US

Education

• UNIVERSITY OF PUERTO RICO, Mayagüez Campus

  BS Chemical Engineering, Chemical Engineering

Skills

• Tableting
• Cross-Functional Team Leadership
• Capa
• Third Party Resource Management
• Sop Development
• Risk Management
• Quality System
• Technology Transfer
• Capsule Filling
• Low & High Shear Granulation
• Ehs
• Quality by Design
• Bottle Filling
• Blister Filling
• Computer System Validation
• Gmp
• Tablet Coating
• Dea
• Project Management
• Operations Management
• U.s. Food and Drug Administration (Fda)
• Wurster Particle Coating
• Process Investigations
• Change Control
• Pharmaceutical Process Development
• Cleaning Validation
• Pharmaceutical Process Technology
• 21 Cfr Part 11
• Validation
• Fluid Bed Granulation & Drying
• Spray Drying
• Pharmaceutical Industry
• Sop
• Lean / Six Sigma
• Fda
• Equipment Qualification
• Roller Compaction
• Process Validation
• Technical Transfers