Today, Lonza is a global leader in life sciences operating across five 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.
What you’ll do:
Primary point of contact between QC customer and CSM for authoring, revising and reviewing of GMP reference standard qualification protocols and reports, primarily for biotechnological reference materials.
Timely completion of qualification protocols and reports enabling LIMS/LES-related activities (MLP specifications, test schedules) and support thereof
Providing technical mentoring and coaching to colleagues within and outside the team in a matrix environment.
Support quality documentation and change management process for reference standards, including review, revision, and timely completion of Trackwise records.
Leading innovation projects within the area of responsibility and identifying opportunities for cost and efficiency optimization.
Providing SME input for project-specific topics during audits and inspections.
Compliance with quality, data integrity, and safety requirements.
Collaboration with QC project leads, QA Analytics, as well as external clients.
What we’re looking for:
Master’s degree or equivalent experience in a Life Sciences discipline (Biology, Chemistry or related field).
Proven experience in a cGMP environment – experience in quality control or analytical development preferred.
Exceptional technical writing skills.
Advanced scientific experience in analytical chemistry/biology.
Extensive knowledge with QC relevant software (e.g. LIMS/LES, DMS, Trackwise, Statistica).
Team player.
Change readiness.
Proficiency in English required – proficiency in German preferred.
Excellent project and time management skills.
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.
Skills Required
- Master’s degree or equivalent experience in a life sciences discipline such as biology or chemistry
- Proven experience in a cGMP environment
- Experience in quality control or analytical development
- Exceptional technical writing skills
- Advanced scientific experience in analytical chemistry or biology
- Extensive knowledge of QC software, including LIMS/LES, DMS, Trackwise, or Statistica
- Proficiency in English
- Proficiency in German
- Excellent project and time management skills
- Team player and change readiness
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
