QC Technical expert mRNA
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 Technical Expert mRNA to join the QC team. The Quality Control Expert implements and executes activities in the Quality Control department in the broadest sense while ensuring compliance with all existing GMP and safety standards. As a Technical Expert you will be required to apply scientific skills, knowledge and experience to provide advice and propose improvements where required.
- Good knowledge and experience of QC methods and instruments
- Expert in QC analysis for API/DS testing: ao. HPLC(Empower), spectrophotometry, residual solvents/impurities (GC), safety tests (like endotoxin), compendial assays
- Expert in assay transfers and assay validations in the applicable QC analysis
- Participates in the initial assessment of new methods to be transferred to QC
- System owner for method specific devices (initiation or review of URS, PQ and define maintenance requirements)
- The technical expert is expected to provide input for problem-solving of issues within his/ hers branch
- He/she is continuously educating and increasing the knowledge in his/her branch
- The Technical expert comes with improvements and ideas to increase efficiency and quality
- The technical expert is aware about the applicable guidelines and very knowledgeable about the ins and outs of her branch
- Familiarizing with development data/results within the applicable discipline as well as building up and sharing of knowledge within the QC department
- Interface with QC employees and contract labs as necessary to identify possible improvements and assess implementation with Supervisor QC
- To advise on and ensure generation, review and approval of QC documents in coordination with other departments and in accordance with cGMP
- Bachelor degree in Pharma/Life Science.
- Extensive experience in QC biologics/vaccines
- Broad understanding of pharmaceutical biological QC test methods for biologics/vaccines
- Practical experience and expert in QC analysis for API/DS testing : HPLC(Empower), spectrophotometry, residual solvents/impurities (GC), safety tests (like endotoxin), compendial assays
- Team player, but able to work independent. 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
- Good organizational and planning skills are required to ensure that pieces of work are completed and reported by agreed deadlines
- Results orientation, Analytical thinking, Thoroughness, Initiative, Critical Information seeking, Ability to Learn are competencies required for this role
- Experience and knowledge in analytical testing of m-RNA vaccines is a strong plus.
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.