Speakers
Meet Our Speakers
Keynotes
Vice President, Head of Quality Auditing and Risk Management
Lonza AG
Division Director-OPQ/OPMA/DPMAII
FDA
Deputy Director, Office of Manufacturing Quality
FDA/CDER
Expert GMP Inspector
MHRA
Senior Vice President for Regulatory Compliance
Eliquent Life Sciences
General Sessions
Vice President Quality North America
Fagron North America
Partner
Barry-Wehmiller Design Group
Deputy Office Director
FDA
Director of Business Development
GBA Life Sciences
CEO & Principal
Amicus GMP Consultants
Vice President
Vitalant
Chief Operating Officer
BioBridge Global
National Expert, Drugs
FDA
Senior Vice President and General Manager, Manufacturing Operations
ImprimisRx
Global Head Cell Therapy Field Application Scientists and Strategic Alliances
Catalent
Advanced Therapy Medicinal Products (ATMPs)
Biopharma Executive
Head of Engineering
Andelyn Biosciences
Senior Director of Manufacturing Operations
Rengenxbio
Head of IT
NecstGen
Vice President, Operations
Bristol Myers Squibb
Principal Consultant, Technical Services
Steris Corp.
Senior Manager Manufacturing Operations
REGENXBIO
Associate Director QA Microbiology
Regeneron Pharmaceuticals, Inc.
Annex 1 – Case Studies & Misc.
Global Senior Manager VHP Technical Services
STERIS
Principal Quality Technical Manager
Genentech/Roche
Strategic Marketing and Aseptic Processing Specialist
I.M.A. Industria Macchine Automatiche Spa
Product Manager for Critical Applications of Single-Use Systems
Sartorius
Product Manager
Tema Sinergie
Director
C&E Solutions BV
Process Expert
Siegfried Hameln
Director in Global Quality – Microbial Control and Sterility Assurance
Merck & Co.
Isolator Design
Project Director
Novo Nordisk
Digital Solutions Manager
SKAN AG
Director of Product Management Pharma, North America
Syntegon Pharma Technology
Senior Scientist GMP Compliance
Franz Ziel GmbH
Associate Director- Aseptic Processing
Terumo Pharmaceutical Services GmbH
Component Quality
R&D Manager and Process Specialist
De Lama SpA
Director, Technical Product Development
West Pharmaceutical Services
VP of Operations
August Bioservices
Strategy and Technical Affairs
Gerresheimer AG
Project Manager
Stevanato Group
Manager of MSAT (Manager of Manufacturing Science and Technology)
Grand River Aseptic Manufacturing
Facility Design
Sr Director - Facilities, Utilities, and Capital Projects
Eli Lilly Italia SpA
VP Quality and Regulatory
Argonaut Manufacturing Services
VP of Operations
August Bioservices
Director Sales Turnkey
Optima Pharma GmbH
Radiopharma High Potent
Sales Director – Americas
Bausch+Ströbel
Sr VP of Technical Sales
Custom Powder Systems
Senior Business Development Manager
University of Iowa Pharmaceuticals
US Business Development and Marketing Director
Bausch+Stroebel Machine Co.
Airflow Testing
MSc
Bausch+Ströbel SE + Co. KG
R&D Engineer
Bausch+Ströbel SE + Co. KG
Associate Director, Drug Product Manufacturing Department
Kyowa Kirin Co., Ltd.
QA Manager
Chugai Pharma Manufacturing Co., Ltd.
Scientist and Modeling & Simulation Lead
Johnson & Johnson
Expert
JGC JAPAN Corporation
Manager
DAIICHI SANKYO CO., LTD.
Sen. Director Pharma Excellence
Syntegon Technology GmbH
Sterile Processing
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader
CRB
Manufacturing Quality Manager
Amgen
Sr. Director of Process Technology
IPS - Integrated Project Services, LLC
Director of Global Strategy and Technology
IPS-Integrated Project Services
Manager of MSAT (Manager of Manufacturing Science and Technology)
Grand River Aseptic Manufacturing
Principal MSAT Engineer
INCOG Biopharma Services
Vice President External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Misc. Case Studies
General Management - Head of Engineering
Siegfried Hameln
Sr. Sterility Assurance Adviser
Cytiva
Head of Technical Services
Jubilant HollisterStier
Co-founder & CEO
White Raven
Executive Director US Sales
SKAN US, Inc.