Head of Process Development LNP

Netherlands, Geleen

Today, Lonza is a global leader in life sciences operating across three 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.

Since 2020, Lonza manufactures an mRNA vaccine against SARS-CoV for a US customer at two different sites in Switzerland and in the US. We are taking pride in having ramped up manufacturing capabilities for this new vaccine within less than 10 month, and we continue to fully focus on the delivery of this important vaccine.

In the future, Lonza strives to support additional innovations in the field of in vitro transcribed RNA, and Lonza is looking for a talent to head the mRNA/LNP Process Development Team, i.e. the Lonza “RNAgeneers”.

The ideal candidate for this role will be experienced in the development of manufacturing processes and analytical methods for the production of mRNA Lipid Nanoparticle (LNP) formulations.

She/he should have a good understanding of technical challenges and potential solutions for development of clinical and commercial manufacturing processes for LNP manufacturing of mRNA drugs.

She/he should be able to offer both scientific and management guidance in the design and execution of new or unique projects. She/he should be able to manage  a lab team using established systems, ensure close collaboration between process development and assay / analytical method development teams, support cross-training, and seamless delivery of department goals. She/he should be able to support positive collaboration and relationship with manufacturing, Quality Control (QC), Manufacturing, Science & Technology (MSAT), project management, and the mRNA business unit as well as Lonza Pharma and Biotech network. She/he should be able to serve as the technical Subject Matter Expert (SME) in client meetings and regulatory audits, support proposal development for existing and prospective clients in conjunction with sales and business development.

Key Responsibilities:

  • Builds and leads a lab scientists and research associates focused on the development of LNP encapsulated mRNA drug manufacturing processes and analytical methods for these compounds.

  • Maintains constant emphasis on safety and ensures a safe working environment for self and others.

  • Owns the development life cycle for multiple projects in parallel. Understands process development based on good manufacturing practice (GMP) design considerations and at-scale cGMP manufacturing process for clinical and commercial manufacturing.

  • Provides technical direction to the project leads and manages technical risks throughout the development and technology transfer process ensuring successful program management and delivery.

  • Drives scope definition and experimental design of process development and analytical methods activities through respective project leaders; aligns goals of the projects with overall project plan including process development, tech transfer to QC and manufacturing (MFG); obtains buy-in from client and removes obstacles to successful completion.

  • Establishes and executes the detailed development project plan including process and assay transfer, development or optimization, process characterization, assay qualification, assay validation and tech transfer of process to MSAT and assays to QC. Working with the Program manager (PM), engages in supporting other functional groups and departments proactively and manages changes to scope and timeline effectively. Actively drives alignment with PM, QC, and MFG on development targets to ensure appropriate process and assay fits and succeeds in manufacturing and release testing.

  • Serves as technical SME in clients’ meeting, regulatory audit; 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.

  • Continually seeks opportunities to improve client satisfaction while keeping Lonza's interests in clear focus.

  • 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 standard development activities and harmonization of global PD initiatives.

  • Prepares and/or reviews development team presentations and reports and provides constructive feedback to address the gaps and risks.

  • Develops and implements lab-related SOP’s, DMR’s, labels, PQA documents, written materials.

  • Develops connections within the Lonza network, contributes proactively to global projects and is known as an industry expert in area of specialty.

Key requirements:

  • Master's Degree or PhD in a life science discipline with extensive experience in development of LNP encapsulated mRNA manufacturing processes and analytical method development for such compounds

  • Strong team leadership and interpersonal skills.

  • Solid knowledge and understanding of current LNP applications, challenges, and strong desire and expertise in developing new innovative technologies to address those challenges.

  • Substantial interest in preparing service proposals for potential customers and managing a service portfolio.

  • Experience in working with clients and managing customer projects.

  • 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.

Reference: R34759