Jose Caraballo

Company: Independent Raw Materials Expert

Bio:

Jose Caraballo Oramas is a recognized authority in biotechnology and cell and gene therapy (CGT) manufacturing, with over two decades of global leadership in quality systems, regulatory compliance, quality engineering, technology transfer, and advanced therapy production. His cross-functional experience spans operations, development, Manufacturing Sciences and Technology (MS&T), and quality—built through leadership roles at Abbott Laboratories, Amgen, Bayer, and Kite, a Gilead Company.

Jose has led more than 75 audits and inspections, overseen quality operations for over $1.2 billion in capital investments, managed global product transfers, and contributed to the successful launch of multiple commercial therapies.

A certified quality engineer and auditor, he has authored guidance for ISPE and PDA on topics including technology transfer, raw material control, biopharmaceutical facility design, and quality systems for biologics and ATMPs. He is known for applying a systems-thinking approach to complex biopharma challenges—particularly in raw material strategy, supply variability, aseptic processing, and patient-centered risk mitigation.

Respected for bridging operational excellence with regulatory insight, Jose remains an active contributor to ISPE and PDA initiatives and regularly shares best practices with the global advanced therapies community through industry forums and his LinkedIn platform.

Seminars:

Completing the QBD Picture Integrating CPPs, CQAs, & CMAs for Smarter Process Design 2:15 pm

Clarifying the distinct roles of CPPs, CQAs, and CMAs in building a robust QBD framework Using risk assessments to identify which raw materials require qualification and why CMAs are key to that process Leveraging a complete attribute-based approach to enhance process understanding and reduce variability in manufacturingRead more

day: Conference Day One