QC Project Lead
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.
Here at Lonza we have an exciting opening for QC Project Lead to join us on site in Geleen on a full time, permanent basis. QC Project Lead is leading 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.
Delivery of services in this role will include, but not be limited to:
- Participates in the initial assessment of new products and processes.
- 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. Supports stability program by gathering information needed to initiate protocols and tracks status of time point summaries. Relays status updates in a timely and accurate manner.
- 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
- Works in cooperation with TD/BAS 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.
- Performs other duties as assigned.
You should have the following experience/knowledge:
- Experience of method transfer required
- Basic knowledge of biological cell based assays such as proliferation/cell count and viability, flow cytometry, ELISA, and PCR preferred
- Prior experience working with cell or gene therapy products preferred
- 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.
- Good organizational and planning skills are required to ensure that pieces of work are completed and reported by agreed deadlines
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.