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.

Job Description:

The Director, Viral Vector Platform will lead implementation, CMC activities and lifecycle management of Lonza's viral vector manufacturing platforms. This role will be responsible for the successful implementation of Lonza's platforms in GMP manufacturing and collaborating with commercial development to build a compelling offer. They will closely support client viral vector 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. This role brings deep expertise in CMC strategies, regulatory requirements, and the manufacturing and analysis of cell and gene therapies, with a strong focus on client relations and project management.

Key Responsibilities:

Lonza Platform Implementation:
• Define manufacturing, analytics and documentation requirements for Lonza VV 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, BLA and MAA while ensuring that CMC data requirements are met.
• Actively manage the lifecycle of the platform through improvements and changes in technology, quality and regulatory requirements.

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.

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.).

Client Relationship Management:
• Build and maintain strong client relationships, acting as a trusted CMC advisor throughout the lifecycle of the program.
• Ensure that client expectations are met or exceeded, delivering high-quality, timely, and regulatory-compliant CMC solutions.
• Support business development teams in scoping new projects, preparing proposals, and engaging with potential clients on CMC-related discussions.

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 program execution

Key Qualifications:

• Ph.D., M.S., or equivalent in Biotechnology, Chemical Engineering, Biology, or related field
• 10+ years of CMC experience within the Level

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.