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.
For Drug Product Services (DPS), our successful DP focused branch located in Basel, Switzerland, we have exciting opportunities! Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment. Are you ready for your next challenge? Apply now and join this outstanding team as Associate Principal Scientist - Bioanalytical Expert !
What You’ll Do:
As an Associate Principal Scientist – Bioanalytical Expert, you’ll contribute your expertise to support analytical development and quality control for biopharmaceuticals. You’ll collaborate with cross-functional teams and provide scientific input to ensure the success of our projects and you are responsible to lead and manage pharmaceutical development projects of drug entities within QCBA from various customers and in different clinical development phases up to market authorization readiness.
Provide scientific oversight and technical guidance for bioanalytical methods.
Act as a subject matter expert (SME) in internal and external meetings and as a single point of contact for project related QCBA topics within the project team.
Accountable for the successful delivery of QC work packages for assigned projects. This includes on-time close out/authorization and provision of required analytical testing results, documents and reports (e.g. transfer, validation, batch release, stability), LIMS specifications, lead of change requests, CAPAs, deviations and OOX events.
Maintains up-to-date knowledge of analytical method capabilities for assigned projects to support the definition of potential Critical Quality Attributes and the analytical control strategy.
Review and approve GMP documentation in line with regulatory expectations.
Support project teams with analytical strategy and risk assessment.
Leads operational optimization and process improvement initiatives with the support of a Group Head as required, e.g. by contributing to the evolution of the Drug Product QC development strategy.
What We’re Looking For:
We’re seeking a highly qualified and motivated individual who brings deep scientific knowledge and a proactive mindset. The ideal candidate will meet the following criteria:
PhD or MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field (PhD preferred).
Extensive experience in bioanalytical method development, validation, and troubleshooting.
Strong understanding of regulatory requirements (ICH, cGMP, GDP).
Excellent communication skills in English, both written and verbal.
Proven ability to manage priorities and deliver results in a dynamic environment.
Experience working in cross-functional teams and engaging with external stakeholders.
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.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.