Session 1: The Value of an Integrated Operational Readiness Approach

2:00 PM – 2:45 PM | West Red Level, Suite 81

The Value of an Integrated Operational Readiness Approach and Getting Serious About Speed to Patient

This presentation by industry leaders will focus on strategies bridging the Gap that Separates Capital Projects and Successful Manufacturing Operations. This industry leader panel discussion will include operational readiness and what industry is seeing for ways to reduce startup delays and drastically reduce project schedule. The end point is holistic project delivery leading to speed to patient.

The Operational Readiness model will be presented by:

Harry Benson, Global Director Human Performance, CAI
Steve Marr, Head of Real Estate, Facilities and Capital Programs, Spark Therapeutics
Jordan Moon, Internal Quality Operations Manager, 2seventy bio
Nathan Temple, Global Director CQV, CAI
Stephanie White, Director Global Validation, Emergent Bio

Harry Benson leads a global business segment to develop and execute programs and processes for operational readiness and improvement with a particular focus on performance. A former nuclear-trained submarine officer and Master Training Specialist, he is an expert in learning solutions design and delivery with over 25 years of experience in applying current methods for organizational effectiveness and learning within highly technical environments. His methods have led to major skill improvement, driving results-based performance for the U.S. Nuclear Navy and companies ranging from small to Fortune 500.

Steve Marr is a global biopharmaceutical executive with extensive experience leading large organizations in the biopharmaceutical and nuclear industries. He spent 26 years in the United States Navy as a nuclear submarine officer where he held several key leadership positions including Commanding Officer of the USS SALT LAKE CITY (SSN 716) as well as Commodore of Submarine Squadron ONE in Pearl Harbor Hawaii. Steve retired from the Navy as a Captain in 2009. After retiring from the Navy Steve spent four years in the civilian nuclear industry working for Areva and then Westinghouse as a project director for large multi-billion-dollar new nuclear facilities. In 2014 Steve transitioned to the pharmaceutical industry. He first joined Shire Pharmaceuticals as a project director and site lead where he successfully delivered a new $2B manufacturing facility. Steve spent 3 years as the Head of Capital Programs for Shire where he was accountable for developing and implementing capital management programs and services with direct oversight of the $1B annual capital budget. Steve joined the Spark team in April 2020 as the Head of Real Estate, Facilities and Capital Programs where he is responsible for leading the evolution of Spark’s expanding corporate facilities portfolio and long-term facilities strategy. He received a B.S in Ocean Engineering from the United States Naval Academy.

Jordan Moon is the Internal Quality Operations Manager for 2seventy bio where he previously served as the Operational Readiness Project Manager for a startup Cell and Gene therapy sterile manufacturing suite as well as QC and Microbiology lab. Jordan has diverse industry experience in both biopharmaceutical as well as sterile manufacturing. Jordan has supported both startup projects as well as routine manufacturing with focuses on manufacturing operations, Quality Assurance, and Critical Utilities.

Nathan Temple serves as the Global Director for CAI, is a PMI® Certified Project Management Professional (PMP) and licensed Professional Engineer with 20+ consecutive years of experience in the fields of start-up, maintenance, commissioning, and qualification. Nathan has extensive engineering, test execution, and project management experience with a wide variety of systems and equipment. Nathan is a computer system validation subject matter expert providing project consulting and support. He is chair of the ISPE C&Q Community of Practice Steering Committee. Nathan is a sought-after expert in the areas of C&Q program implementation and optimization with emphasis on integrated C&Q and operational readiness.

Stephanie White, MS is currently the Global Validation Director at Emergent Bio Solutions. She has 20+ years’ experience in the biological pharmaceutical industry working in R&D, drug substance, drug product, fill-finish, and combination products. She also is engaged with ISPE as a member of the C&Q Steering Committee and was a co-author with other industry profession on Good Practice Guide: Good Engineering Practice, Volume 2. Her passion is to help standardized engineering and validation processes resulting in increased efficiencies and effectiveness providing value to capital project delivery.