Director, Cell Therapy Platform Lead

About the position

The Director of Cell Therapy Automated Process and Analytics Platform at Lonza will lead the development and implementation of automated processes and analytics for cell therapy in a GMP-compliant environment. This role involves supporting client cell therapy programs and acting as a technical liaison to ensure projects meet quality and regulatory standards for successful IND/BLA submissions. The ideal candidate will leverage their technical and CMC expertise, strategic vision, and leadership skills to drive innovation in collaboration with internal teams and external partners.

Responsibilities

• Define strategy for closed automated manufacturing of cell therapies, rapid testing and release with electronic data management.
• Define manufacturing, analytics and documentation requirements for Lonza CT platform processes to address client program CMC needs.
• Lead a matrix team consisting of technical, operational, quality and commercial team members to successfully implement the platform in manufacturing and build a comprehensive platform process offering through IND and BLA ensuring that CMC data requirements are met.
• Actively manage the lifecycle of the platform through improvements and changes in technology, quality and regulatory requirements.
• Stay up to date on progress in the field especially related to regulatory requirements and associated analytics (ex. Potency testing, comparability strategy and analytics etc.).
• Work closely with R&D to identify, develop and implement advanced analytics and PAT for Cell therapy processes to improve process and patient outcomes.
• Serve as the primary CMC expert for platform client programs, providing strategic guidance and technical oversight from early development through commercial production.
• Act as a technical point of contact for all platform CMC-related matters, including process development, analytics, scale-up, regulatory filings, and technology transfer.
• Foster a strong relationship between internal teams and clients to ensure smooth communication and execution of manufacturing activities.
• Work with Lonza regulatory experts to guide clients through the preparation and review of CMC sections for regulatory submissions (INDs, BLAs, MAAs), ensuring compliance with global regulations.
• Provide expert technical support during client meetings with regulatory agencies and audits.
• Build strong collaborations with CMC experts in other BUs/Divisions.
• Stay connected with industry consortia and external experts / thought leaders.
• Collaborate with internal technical operations, regulatory, quality, and business development teams to ensure successful delivery and commercial traction for the offering.

Requirements

• Ph.D., M.S., or equivalent in Biotechnology, Chemical Engineering, Biology, or related field
• 10+ years of experience within the biopharmaceutical industry, with a minimum of 5 years specifically in Cell Therapy process.

Benefits

• Opportunity to work in a global leader in life sciences
• Engagement in meaningful work that improves lives
• Collaborative and innovative work environment