Michael Magee Email & Phone Number

Owner and Principal Consultant

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Michael Magee Location

New York, NY, US

Michael Magee Work

Owner and Principal Consultant @ Kenformete Solutions, LLC (September 2025 - Present)
Lead Auditor, 503B Accreditation and GMP Compliance @ (October 2025 - Present)
Senior Associate @ (September 2025 - Present)
Innovation Advisory Board Member @ (February 2025 - Present)
Vice President, Quality and Compliance @ (February 2024 - September 2025)
Sr Vice President, Quality @ (January 2021 - January 2024)
Vice President, US Quality Assurance @ (January 2015 - January 2021)
Vice President, Quality Operations @ Windtree Therapeutics, Inc. (January 2011 - January 2015)
Principal Scientist, Parenterals Platform, Global Technical Services @ (January 2009 - January 2011)
Director, Quality Assurance @ (January 2004 - January 2009)
Associate Director, Quality and Validation @ (January 2002 - January 2004)
Business Unit Manager – Pharmaceutical Processing and Packaging @ (January 2001 - January 2002)
Operations Excellence Leader @ (January 2000 - January 2001)
Facility Manager, Biological Manufacturing @ ORTHO BIOTECH PRODUCTS LP (Johnson & Johnson) (January 1996 - January 2000)

Michael Magee Education

Moravian University
BS (Chemistry)
Saint Joseph's University Philadelphia College of Pharmacy
Bachelor of Science (Pharmacy)

Michael Magee Skills

503B Outsourcing Facility Compliance
Aseptic Processing
Biopharmaceuticals
Biotechnology
Board Level
Business Strategy
CAPA & Deviation Management
Coaching, training, and quality culture
Crisis Management and Business Continuity
Cross-functional Team Leadership
Due Diligence / Mergers and Acquisitions
FDA
Gap Analysis, Maturity Assessments
Inspection Readiness (FDA, EMA, State Boards of Pharmacy)
Inspection readiness, inspection management, and responses
Life Sciences
Medical Devices
Pharmaceutical Industry
Pharmaceutical Quality System (PQS) / Quality Management System (QMS)
Project Management
Quality Strategy and Governance
Quality Strategy and Roadmap
Risk Management
Sterile Manufacturing & Aseptic Processing
Strategic Planning
Technology Transfer
USP <795, 797, 800> Compounding Standards
cGMP / GxP Compliance
Analytical Chemistry
Clinical Trials
Quality Assurance
Pharmaceutics
ISO 13485
Global Health Authority Gmp Inspections
New Product Introductions
Drug Development
Quality Management System Design/Implementation
Sales
Formulation
Regulatory Affairs
Computer System Validation
Regulatory Requirements
Sop
Quality Management
Problem Solving
Product Development
Root Cause Analysis
Operations Management
Cross Functional Team Leadership
Microbiology
u.s. Food and Drug Administration Fda
Microsoft Office
Quality System
Leadership
Validation
GxP
Standard Operating Procedure Sop
21 CFR Part 11
Talent Management
Laboratory
Cleaning Validation
CAPA
Process Design and Qualification
Regulatory Submissions
Facilities Management
Process Improvement
Change Control
GLP
IND
Quality Control
GMP
Strategic Business Planning
V&V
Verification and Validation V&V
Matrix Management
Corrective and Preventive Action Capa
Facility Management
u.s. Food and Drug Administration
Corrective and Preventive Action

Michael Magee Summary

Michael Magee, based in New York, NY, US, is currently a Owner and Principal Consultant at Kenformete Solutions, LLC. Michael Magee brings experience from previous roles at Coalition for Compounding Excellence, Gates Healthcare Associates, Inc, GxP Training : #1 Certified Online Courses Provider for Life Sciences Profession and Tris Pharma. Michael Magee holds a BS in Chemistry @ Moravian University. With a robust skill set that includes 503B Outsourcing Facility Compliance, Aseptic Processing, Biopharmaceuticals, Biotechnology, Board Level and more. Michael Magee has 4 emails and 5 mobile phone numbers on RocketReach.