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CQV strategies to optimize cell therapy manufacturing

When building a cell therapy manufacturing facility, having a defined CQV (Commissioning, Qualification, and Validation) strategy is critical to project success. In this webinar co-sponsored by Precision ADVANCE and Project Farma, our panel of industry experts discuss tips for delivering efficient, reliable, GMP-compliant facilities and processes specific to cell therapy.

Attendees will have the opportunity to learn:
  • Key factors for assembling an experienced and flexible team
  • The importance of process knowledge, including equipment and design
  • Quality-by-design principles and GAMP guidelines
  • About automation, emerging bioreactor, single-use, and disposable technologies
  • How to optimize speed-to-market by applying innovative COTS strategies, vendor documentation, out of place commissioning, and more
  • Tips for navigating the regulatory landscape
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Jenna McDaniel

Jenna McDaniel

Director, Project Farma

Jenna McDaniel is a Director at Project Farma. In her role, Jenna provides biotech strategy, manufacturing startup, and global manufacturing network experience to support client initiatives and company goals. Jenna brings portfolio and project management skills to the forefront as she forecasts high-level projections in collaboration with Project Farma clients.

Jenna has 12+ years of biotechnology and has launched numerous cell therapies, immunotherapies, and other biologic based drug products throughout her career including an international role for global CAR T manufacturing.

Joel Ortiz

Joel Ortiz

Director, Program Management, Iovance

Joe Ortiz is a Director of Program Management at Iovance Biotherapeutics. He is an experienced Site Validation Manager with a demonstrated history of working in the biotechnology industry. Joel is skilled in U.S. Food and Drug Administration (FDA), Corrective and Preventive Action (CAPA), Change Control, Validation, and GMP.

He is a quality assurance professional with a Bachelor of Science focused in Chemical Engineering from North Carolina State University.

Nathan Traughber

Nathan Traughber

Director, Project Farma

Nathan Traughber is a Director at Project Farma. With over 12 years of experience in the Biologics and Advanced Therapies industries, Nathan has a proven track record of successful engineering project management in an FDA regulated environment. This success comes from a strong multidisciplinary background in engineering, validation, quality, manufacturing, and infrastructure.

In the Biologics space, Nathan has successfully implemented tens of millions of dollars in GMP engineering projects. He often served multiple simultaneous project roles such as Project Manager, Engineering Technical Lead, Qualification & Validation Lead and others as projects required.

At Project Farma, Nathan has spent the last 4 years deeply engaged in Advanced Therapies and has supported clients in various stages of clinical and commercial growth. His strong GMP capital project background has enabled him to support strategic planning and execution of significant manufacturing expansions.

Wilbur Williams

Wilbur Williams

Quality Engineering, Kite Pharma

Wilbur Williams has been an industry professional in clinical laboratories, biotechnology and pharmaceuticals for more than 19 years. He started his engineering career as a project manager for an industrial machine shop in Puerto Rico, then moved into the pharma/biotech space as a Validation Engineer supporting major capital projects and new facility startups for companies such as Lilly del Caribe, Wyeth Pharmaceuticals, and Amgen. After relocating to Maryland in 2008, Wilbur became the CQV Lead for the construction and startup of AstraZeneca’s biologics bulk facility in Frederick, Maryland, formerly known as MedImmune Building 633. The complex nature of the project, short timeline, and novel approach to startup, CQV, and ops training earned the project ISPE Facility of the Year award category winner for Project Execution, later receiving the overall 2011 Facility of the Year award.

After this, Wilbur moved to AZ Biologics HQ in Gaithersburg where he built an ISO50001/ANSI MSE-50021 certified energy management system making his site the first Bio/Pharma site in the world to be certified by ISO, and the Superior Energy Performance program from the Department of Energy. Once more, Wilbur’s CQV expertise was needed and he rejoined the AstraZeneca Global Engineering Organization as a CQV Lead where he planned and oversaw major Global Capital Projects that spanned from small scale biologics facilities to large aseptic vial and syringe filling operations.

In 2018 Wilbur joined Kite as the CQV Lead for Global Quality Engineering, helping out plan and deliver several CGT facilities in 2019, including the early concept and planning of the Cell Therapy Operation commercial operation being built in Maryland where he now leads the Quality Engineering organization.

Jim Watson
moderator

Jim Watson

Vice President, Project Farma

Jim Watson has 25+ years of experience in the pharmaceutical industry. He is a Vice President at Project Farma, has led development of Project Farma’s presence in the East Coast, and been a leader on its cell and gene therapy task force. He started his career designing, building, and starting up membrane plants, to eventually managing large scale capital projects and leading engineering, maintenance, capital projects and EHS disciplines at a leading CMO.

Jim has extensive experience in high purity utilities, large molecule biological processes and advanced therapies. He has worked for small and established pharmaceutical and biotech organizations launching early phase manufacturing strategy, conceptual design, user requirement specifications, verification, validation, facility turnover and facility operations.

Jim graduated with a BS in Chemical Engineering from Worcester Polytechnic Institute and is completing an MBA through the University of Central Oklahoma.