Maximizing Production Capacity for Growth Part 3: Defining Low Cost in Your Solution for Future Facilities

Carrier Li, Director in Global Asset Planning, Amgen

Carrier Li is Director in Global Asset Planning supporting Manufacturing Asset Planning at Amgen. He has 28 years of experience in the bioPharmaceutical industry. Prior to Amgen, Carrier was Project Design Manager at Merck leading Front-End Planning activities in Central Engineering. Carrier has a bachelor’s degree in Chemical Engineering.

Bob Allen, Senior Director, Facilities Integration, Fluor Industrial Services

Bob began his professional career with Fluor more than 29 years ago after receiving his bachelor’s degree in architecture from Clemson University. His work as a technical director within Fluor’s Facilities Integration Group has given him exposure to a wide range of life sciences and health care projects with industry leading companies such as the Cleveland Clinic, Amgen, Genentech, Biogen, Monsanto, IDEC, Roche, Schering AG, Novo Nordisk, Novartis, and Elan Pharmaceuticals.

His particular area of expertise is the early scope definition and conceptual design of GMP and regulatory compliant biotech and Pharmaceutical facilities. Project type, size, and complexity have varied greatly and include fill/ finish, process development, pilot plant, clinical, launch, and commercial manufacturing facilities in the U.S., Canada, Europe, Middle East, and Asia. He is intimately familiar with all applicable GMP/regulatory compliance issues, bioPharmaceutical unit operations, and associated ancillary support equipment.

Bob is a registered architect and a LEED accredited professional and well versed in sustainable building design principles.

Craig Sandstrom, PhD, Director of Process Engineering, Fluor Industrial Services

Craig is one of Fluor’s resident biotechnology experts and is a Director of Process Engineering within the Industrial Services business. He received his PhD in Chemical Engineering from Northwestern University and has more than 21 years of industry experience, with the last 17 years working with Fluor. During this time, he has worked dozens of bioPharmaceutical facility design and optimization efforts, with an installed value in excess of $1.6 billion. These manufacturing facilities have included both drug substance and final drug product, with products including recombinant proteins (monoclonal antibodies, enzyme replacements, hormones, and growth factors), vaccines and human plasma derived proteins, with manufacturing scales ranging from 500 to 20,000 liters (bioreactor or fermenter capacity) for the drug substance facilities and from 5MM to 50MM vials/syringes per year. More recently, Craig has been leading Fluor’s process efforts around facility optimization and capacity planning, focusing on overall equipment effectiveness and operational consistency to unlock existing capacity with minimal facility impacts.