Speakers
Meet Our Speakers
Keynote Speakers
Drug National Expert
FDA/ORA
Senior Consultant Aseptic Processing & Containment
SKAN AG
Senior Vice President, Indianapolis Parenteral Manufacturing
Eli Lilly and Company
President
Genesis AEC
Senior Engineer
FUJIFILM Diosynth Biotechnologies
Global Head Compliance and Inspection Management
Moderna
Senior Director, Quality Strategy & Operations
Alnylam Pharmaceuticals
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader
CRB
Director, Division of Case Management
FDA/CBER/OMPT/OCBQ
CEO
TAG1 Inc.
Manager of MSAT (Manager of Manufacturing Science and Technology)
Grand River Aseptic Manufacturing
Advanced Modalities
Process Engineer
CRB
Senior Project Manager Tech. Transfer
ITM Medical Isotopes
Process Engineer
CRB
Senior Engineer
LOTTE Biologics
Technical Sales Manager
Optima Machinery Corporation
Senior Process Engineer
Merk
Associate Director GMP / QP
Kyowa Kirin
CEO
Orchestra Life Sciences
Director, Innovation & Engineering
Nucleus RadioPharma
Advanced Therapy Medicinal Products
Projects Technical Manager
AstraZeneca
Process Engineer
CRB
Sr Director F&E
Kite Pharma, Inc.
Principal Consultant, Technical Services
Steris Corp.
Head of Drug Product Manufacturing
Ultragenyx Pharmaceutical Inc
Associate Director QA Microbiology
Regeneron Pharmaceuticals, Inc.
Principal Project Manager
Takeda Pharmaceuticals Company
Sr. Manager, Engineering
Ultragenyx
Case Studies
General Management - Head of Engineering
Siegfried Hameln
Sr Director - Global Quality Systems
Lilly
Director Tech Ops and Bridgeton MFG
Kindeva Drug Delivery
Senior Engineer
FUJIFILM Diosynth Biotechnologies
Director of Construction Operations
CRB Group
Senior Engineer
FUJIFILM Diosynth Biotechnologies
Vice President Sales Turnkey
OPTIMA Pharma GmbH
Executive Director North American Sales
SKAN US, Inc.
Founder and President / Sr, Consultant
Steed MicroBio LLC / JYA
Director-Engineering • Pharma Engineering Center
Eli Lilly & Co Mfg & Quality Learning Ctr
Senior Product Manager
Syntegon Technology GmbH
Filling Operations
Senior Technology Center Manager
Fedegari Technologies Inc
Senior Innovation Manager
IMA Life
Technical Services Specialist
Steris Corporation
Principal Consultant, CQV & Regulatory Science
Arcadis
Business Development Director
3P Innovation
Director Advanced Technology Development and Innovation
Syntegon Technology GmbH
President
Dalton Pharma Services
Global Director Business Development
Bausch+Ströbel SE + Co. KG
Regulations and Pharma 4.0
Process Development Scientific Director
Amgen
Specialist, Manufacturing Development
Novo Nordisk
President
Genesis AEC
Process Development Scientist
Amgen
Senior Manager, Technical Services
STERIS Corporation | Life Sciences
Director, Drug Product, Device & Combination Product
Astrazeneca Limited Partnership
Team Lead AVI Projects
Vetter Pharma-Fertigung GmbH & Co KG
Senior Subject Matter Expert - Aseptic Fill Finish
WuXi Biologics Germany GmbH-Germany
Sterility and Release
Associate Director Quality Control
Sumitomo Pharma America
Global Senior Manager VHP Technical Services
STERIS
Laboratory Manager, Analytical Science Laboratory, Development Service
Vetter Pharma-Fertigung GmbH & Co KG
President
Airex Co., Ltd.
Professor
The University of Tokyo, Department of Chemical System Engineering
Senior Director Manufacturing Operations
Sumitomo Pharma America, Inc.
Founder, Owner
C&E Solutions BV