Webinar: Manufacturing in Turbulent Times

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Biopharma manufacturing is heading into its most volatile stretch in a decade. Capacity constraints, geopolitical pressure, regulatory scrutiny, and technology fragmentation are converging to create a new era of operational risk. As a result, sponsors and CDMOs and CMOs are requiring stronger integrations in their partnerships.

This webinar gives sponsors a clear, practical framework for evaluating CDMO/CMO partners who can withstand these pressures — and help you avoid the delays, compliance issues, and scale‑up failures that derail programs. Attendees will leave with a sharper understanding of the challenges ahead and a concrete checklist for choosing partners built for the next five years, not the last five.

This webinar aims to help attendees:

• Understand the next wave of manufacturing challenges — from regulatory tightening to supply‑chain instability and technology shifts.
• Avoid manufacturing and regulatory pitfalls that commonly stall programs, from process‑transfer gaps to compliance blind spots.
• Identify the traits of a future‑ready CDMO/CMO, including operational resilience, digital maturity, and transparent governance.
• Evaluate partnership fit with confidence, using a structured due‑diligence lens that reduces risk and accelerates timelines.

Jin Liu

CMC Consultant | GeneVoyager

Jin Liu, PhD, PMP, serves as a CMC Consultant at GeneVoyager and is a recognized leader in cell and gene therapy development. With more than 20 years of biotechnology experience, she has advanced multiple AAV gene therapy, CAR-T, NK cell therapy, stem cell, and exosome programs from early development through GMP manufacturing, technology transfer, IND submission, and clinical translation. Previously, Dr. Liu served as Director of QC-GLP and MSAT at the University of Pennsylvania Gene Therapy Program under Dr. James Wilson. She is currently Founder and CEO of GenCell LLC, where she is developing next-generation AAV-mediated in vivo immune engineering platforms for solid tumors. Her expertise spans CMC strategy, process development, GMP operations, quality systems, technology transfer, and translational product development.

Ashley Craddick

Vice President of Operations | Forge Biologics

Ashley Craddick, MBA, is Vice President of Operations at Forge Biologics, where she provides strategic and operational leadership across manufacturing operations. As Forge’s first employee, Ashley played a foundational role in building the company’s cGMP manufacturing capabilities and has helped scale its operations to support a growing portfolio of clinical programs while advancing Forge’s late-phase and commercial manufacturing capabilities.

With more than 15 years of experience in cell and gene therapy, Ashley brings deep expertise across process development, cGMP manufacturing, and CMC. Prior to Forge, she held leadership roles at Scout Bio and Nationwide Children’s Hospital. Ashley is recognized for pairing technical depth with strong organizational leadership, building high-performing teams and advancing manufacturing strategies that support operational excellence, client needs, and long-term business growth. Ashley holds a B.S. in Chemistry from Urbana University and an MBA in Organizational Leadership from Franklin University.

Tiffany Rau

Founder | Rau Consulting

Dr. Tiffany D. Rau is Co-Founder of BioPharma Technical Consulting (Ireland) and Founder of Rau Consulting (USA). She is an internationally recognized expert in bioprocessing, Chemistry, Manufacturing and Controls (CMC), GMP manufacturing, quality systems, regulatory compliance, and operational excellence, and is a certified Six Sigma Master Black Belt.

With global experience spanning product development through commercial manufacturing, Dr. Rau has worked across a wide range of therapeutic modalities, including monoclonal antibodies, antibody-drug conjugates (ADCs), radiopharmaceuticals, sterile drug products, cell and gene therapies, and other advanced biopharmaceutical products. She has led and supported the design, start-up, and operational readiness of clinical and commercial manufacturing facilities worldwide while partnering with regulatory agencies and industry leaders to ensure compliance and inspection readiness.

Dr. Rau has advised on more than 150 projects involving process optimization, technology transfer, scale-up, and continuous improvement. She also serves as an Adjunct Professor at University College Cork, Ireland, specializing in CMC, GMP manufacturing, and quality systems.