Oorspronkelijke vacature omschrijving:

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.

We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic.

Lonza Geleen is looking for a QC Project Lead mRNA to join the QC team. The QC Project Lead, leads the introduction of new methods and processes into the Quality Control department via the technology transfer process, represents the department in project teams, and manages the data of the applicable project

Key responsibilities:

• Own, manage and monitor: Technology transfers of QC API test methods related to mRNA vaccine testing, campaign support and readiness/delivery, capital projects. Regularly assess manufacturing execution to ensure no process drift.
• Good understanding of QC testing and QC assay transfer of HPLC assays, residual impurities (GC), endotoxin, compendial assays.
• Attends internal and external project core team meetings and regularly interacts with the client.
• Supports on time delivery on assay transfers and manufacturing process specific change controls, CAPA’s, Support Investigation Reports, Validation activities
• Visualize the progress of the project status/milestones and deliverables, flags concerns and risks in time to management and team, proposes mitigations and has a problem-solving oriented mind-set
• Drive and own improvement internal and cross-functional projects that support department KPI’s, with a focus on cost, innovation, on-time delivery and quality
• Manage projects from concept to completion; create and manage project plan, work cross functionally to ensure right first time and provide adequate training to impacted areas.
• Mentoring individuals or teams, managing any temporary labor
• Provides input to program management regarding Quality Control capabilities and requirements for method transfer. Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
• Provides technical review of Statements of Work and Work packages to support contract manufacturing activities.
• Provides Quality Control representation to project team meetings. Responsible for relaying pertinent information such as production schedules and information requests to applicable Quality Control groups. Provides routine feedback regarding tech transfer and testing status.
• Writes, reviews, and/or approves method transfer related protocols/ reports and assessments.
• Leads tech transfer activities related to Quality Control including generation of a Quality Control method transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines
• Coordination of stability and providing protocol, additional sample request and reporting. Relays status updates in a timely and accurate manner.
• Works in cooperation with the network and sending/transferring site to do initial assessment of the methods to be transferred.
• Is informed on procurement, setup, and validation activities for new equipment and materials required to support new methodology.
• Assists with responses to audits, deviations, out of specification investigations, and corrective/preventative actions applicable to the owned project.

Key requirements:

• Bachelor degree in Pharma/Life Science.
• Extensive experience of method transfer is required
• Knowledge of m-RNA related QC test for API/DS testing: HPLC assays, residual impurities (GC), endotoxin, compendial assays
• Good inter-personal skills to communicate effectively with a range of contacts within the team, multi-departmental and through direct communication with (project) managers or clients
• Able to develop and deliver training programs for specialized and advanced activities.
• Aids in development of training plans and identification of training gaps.
• Demonstrates flexibility to adapt to changing business priorities.
• Ability to collaborate in a team, work inter-departmentally and with customers.
• High level of suite specific operations and technical skills.
• Demonstrates role model behaviors for operating in a GMP manner.
• Demonstrates role model safety behaviors
• Strong written and verbal communication skills
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• Demonstrate sound decision making, considering broad scope of factors
• Able to manage multiple priorities and achieve results.
• Good ability to complete assignments under tight timelines, and work under pressure.
• Demonstrates knowledge on continuous improvement within the adherence to standardized procedures & cGMP compliance

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.