Dave Wigley

About Dave Wigley

Effective professional with experience managing product launches, resolving manufacturing…

Experience

1. Director of Pharmaceutical Development and Technical Operations

   Almirall

   Jul 2013 — Present · Exton, PA, US

   Ensure adequate test methods through method development, validation, optimization and method transfer procedures.Direct and oversee third parties that conduct analytical compound characterization, testing of raw materials, intermediates, active pharmaceutical ingredients, excipients and drug products, Ensure robust product manufacturing processes through adequate formulation development.Direct preformulation activities, formulation development for animal testing, compound performance characterization, excipient compatibility, formulation screening, manufacturing process optimization activities.Provide analytical and formulation support for Preclinical Toxicology, Clinical Development, Process Development and Scale-up, Commercial Manufacturing, and Quality Control.Ensure proper documentation of scientific results.Prepare and update regulatory documents and sections of regulatory submissions.Develop and maintain a collaborative working relationship with external manufacturing/testing partners during development, process transfer and routine analysis.Direct method optimization, transfer and validation programs. Review and assist process optimization, transfer and validation programs.Respond to technical questions and problems. Oversee the conduct and complete reports on scientifically rigorous investigations of aberrant data and out of specification results.Provide expert input during test site, process and manufacturer selections.

Education

• Michigan State University

  BS, Packaging Sciences

  1984 — 1987

Skills

• Drug Development
• Cross-Functional Management
• Clinical Trials
• Medical Devices
• Capa
• Quality System
• V&V
• Medical Devices / Pharmaceuticals (Lcm)
• Process Simulation
• Strategy
• Regulatory Requirements
• Biotechnology
• Change Control
• Cross-Functional Team Leadership
• Manufacturing Troubleshooting
• Software Documentation
• Commercialization
• Pharmaceutical Industry
• Sop
• Fda
• Product Development
• Technology Transfer
• R&D
• Management
• Manufacturing
• Program Management
• Product Launch
• Pharmaceutics
• Project Management
• Quality Control
• Validation
• Gmp
• Clinical Development
• Regulatory Affairs
• Regulatory Submissions
• 21 Cfr Part 11
• Process Improvement