The actual location of this job is in Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
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 Contract Development and Manufacturing Organization (CDMO) branch, we have an outstanding opportunity within the Analytical Project Leadership team. Are you ready to become part of a dynamic group that supports Customers in the development of their CMC strategy and enables them overcoming some of the greatest challenges required to bring therapies to life? Apply now!
Key responsibilities:
Lead analytical discussions with customers and collaborate with Subject Matter Experts (SME) representing all Analytics groups across the Lonza network including DS and DP sites
Set-up strategy for DPS analytical programs: Control strategy from pre-IND to BLA (QbD, ATP, QTPP, CQA assessment, ATA), specifications and justifications for specifications, analytical method lifecycle (monitoring of performances of platform methods and product-specific methods).
Maintain up-to-date knowledge of assigned molecules, method strategy, industry issues/trends and pharmacopeia as well as adhere to cGMP regulations
Lead development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing
Ensure project timelines and deliverables are visible and maintained in relevant planning tools
Support Project Managers with technical review analytical SOWs and engage with SMEs as well as amendments team as required
Key requirements:
Master degree (PhD is a plus) in Biochemistry, Pharmaceutical Sciences, Analytical Science or related field
At least 5 years of experience working as Analytical and/or QC Project Lead in late clinical phase projects
Proven knowledge of analytical lifecycle for biotechnology products, CMC requirements for regulatory filings (IND and BLA)
Very good knowledge in relevant analytical techniques and protein analytics
Experience working in analytical development and/or QC preferably with cGMP experience
Ability to interpret complex analytical data and provide solution with hands on mentality to the Customer
Excellent communication, reporting and scientific 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.
