Head of Cell Therapy Development
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
We are currently looking for a Head of Cell Therapy Development to join our team in the Netherlands. As Head of Cell Therapy Development you will be responsible for Developing the manufacturing process based on GMP design considerations, standard process development and assay development guidelines. You will work on process design problems where analysis of situations or data requires a broad knowledge of relevant technology and consideration of analytical methods and in process controls. You will Exercise judgment on current state-of-the-art procedures and practices to determine appropriate action. This all relies on guidelines related to cGMP manufacturing and appropriate regulatory requirements in designing new processes and developing new assays.
- Leads a team of 15-20 Research Associates, Scientists, scientific managers focusing on process development and/or bioassay / analytical methods development for cell and gene therapy (CGT) manufacturing.
- Maintains constant emphasis on safety and ensures a safe working environment for self and others.
- Owns the development lifecycle for multiple projects in parallel; provides technical direction to the project leads and manages technical risks throughout the development and technology transfer process ensuring successful program delivery. Drives scope definition and experimental design of development activities (process development and bioassay) through respective project leaders, aligns goals of the project with MSAT, manufacturing (MFG) and Quality Control (QC), obtains buy-in from client and removes obstacles to successful completion.
- Establishes and executes the detailed development project plan including process development and Bioassay activities from process / assay transfer, optimization, qualification, and tech transfer. Working with the PM, engages supporting departments proactively and manages changes to scope and timeline effectively. Actively drives alignment with MSAT and MFG on process development targets to ensure appropriate process fit and success in manufacturing. Drives alignment with QC on analytical methods deliverables to ensure fit for purpose and successful deployment in QC.
- Keeps project manager updated on progress and challenges, and serves as liaison between development staff and other departments.
- Manages team resources using established systems and ensures close collaboration with other Development Managers to support cross-training, dynamic resource management and seamless delivery of department goals.
- Serves as technical SME in client/regulatory audits, supports proposal development for existing and prospective clients in conjunction with sales and business development.
- Develops and mentors direct reports through challenging assignments and providing constructive feedback, goal setting and monitoring performance on a routine basis (via formal and informal channels), and ensuring that overall project goals are on track.
- Fosters a positive and collaborative work environment across the department and site; supports, communicates and manages change driven from within and outside the department effectively. Encourages open communication.
- Supports the Development, Operations, and Site management to implement standard processes and new initiatives that helps addressing quality, safety, and operations challenges.
- Develops and maintains strong client connections founded on technical leadership, strong execution and solid communication.
- Continually seeks opportunities to improve client satisfaction while keeping Lonza's interests in clear focus.
- Supervises process development/bioassay services labs directly or through team to ensure that they are fully capable, operationally efficient and safe. Pays specific attention to cleaning, safety, 6S and EPS compliance.
- Proactively and independently works with other managers and department heads to resolve conflicts or gain alignment prior to escalation.
- Owns and drives the implementation of global streamlined standard CGT development services best practices
- Identifies and escalates process risks, prepares project progress summaries appropriate for management / client review. Prepares and reviews presentations, protocols, PD reports and Analytical Development reports.
- Develops and implements departmental SOP’s and production batch records and non-GMP / relevant documents. Understand at-scale cGMP manufacturing process and constraints to develop principles for process and analytical development in the lab and successful transfer.
- Develops strong connections within the Lonza network, contributes proactively to global projects and is known as an industry expert in area of specialty.
- Focuses on increasing Lonza's presence in the Cell and Gene Therapy industry through conference presentations, seminars.
- Associate director level: Master's Degree in a life science discipline with over 15 years including over 10 years supervisory experience, or Ph.D. in a life science discipline with 10-15 years of post-graduate experience including 5-10 years supervisory experience with analytical method development for cell and gene therapy related topics.
- Senior Manager level: Master's Degree in a life science discipline with 10-12 years including 4-5 years supervisory experience, or Ph.D. in a life science discipline with 6-8 years of post-graduate experience including 3-4 years supervisory experience with bioprocessing applications and / or cell therapy related topics.
- Extensive experience with development of manufacturing process or analytical methods for various cell and gene therapy applications using different cell culture systems for stem cells, T cells, and/or other tissue specific cell types.
- Strong desire in developing new technologies, processes and service offerings for the cell and gene therapy market.
- Solid knowledge and understanding of current cells and gene therapy applications and challenges
- Substantial interest in preparing service proposals for potential customers and managing a service portfolio.
- Multiple years of previous supervisory experience with strong team leadership and interpersonal skills.
- Experience in working with clients and managing customer projects.
- Strong track record of translating new product ideas into project plans and executing them by assigning resources as well as tracking project progress toward milestones and deadlines.
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.