Director, Cell Therapy Platform Lead

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Director of Cell Therapy Automated Process and Analytics Platform will lead the development and implementation of closed automated processes and
analytics for cell therapy within a GMP-compliant environment. They will closely support client cell therapy programs and will serve as a technical liaison between Lonza and client teams, ensuring that projects meet current quality and regulatory standards for successful IND/BLA submissions. The ideal candidate will combine technical and CMC expertise, strategic vision, commercial acumen and leadership skills to drive platform innovation through a matrix team including Lonza functions and external technology partners.

Key Responsibilities:

Automated CT platform development and implementation:
• 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.

Analytical Development & Quality Control:
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.

Client Program CMC Leadership:
• 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.

Cross-Functional Collaboration:
• 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

Key Qualifications:

• 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