プロフィール詳細

プロジェクトを作成

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Matt P.に依頼

United States

Expert Biopharm training, technical writing, cGMP/quality systems, & performance consultant w/ 30 years experience

プロフィール概要

Quality Learning and Development (L&D) and performance improvement change agent with 30 years’ experience in cGMP manufacturing environments. Transformed learning and SOP writing strategies at multiple organizations as L&D leader from a focus on traditional compliance and administration to performance consulting and delivering holistic improvement solutions. Designed and delivered interactive, transformative training with demonstrated results for Human Error Prevention, SOP Writing, cGMP, Data Integrity, Investigations & CAPA, technical training, and more, as an expert in both content, and adult learning and facilitation. Streamlined and aligned Training and Documentation Management teams as Quality systems manager. Executed and managed all aspects of downstream GMP Manufacturing Operations and teams for 10 years.

専門分野

• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Pharmaceutical Management
• ☆ Skills Training
• ☆ Instructional Materials
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Course Content Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Non-Medical Regulatory Writing, Technical Writing

Research Market Research

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis

Product Development Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Consultant/Owner

BioPharm Error Prevention Associates, Inc.

6月 2021 - 現在

Head of Learning & Development, Viral Vector Services Division

Thermo Fisher Scientific

4月 2019 - 4月 2021

Director of Learning & Development, North America

Sanofi

4月 2012 - 4月 2019

学歴

Biology

Northeastern University

9月 1993 - 6月 1996

BS Biology

Boston College

9月 1987 - 5月 1991

BA/Secondary Education

Boston College

9月 1987 - 5月 1991

認定資格

• cGMP Training Manager

  PDA

  1月 2005 - 現在