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.

Located in Stein/Basel, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Project Lead Commercial QC for a new sterile Drug product facility to support quality control and manufacturing related project activities.

Key responsibilities: 

• Enable release and stability testing of late phase (PPQ and Commercial) Drug Product, specifically for analytical testing of Antibody Drug Conjugates (ADC`s)
• Support of laboratory planning as well as introduction and transfer of Analytical test methods to enable Drug Product release and stability testing
• Represent Lonza in internal and customer meetings as project champion
• Demonstrating knowledge of analytical testing by e.g. compendial and generic methods, HPLC and (i)CE purity methods, content determination, Bio-chemical methods (ELISA, SPR, Cell based potency / binding / activity assays), qPCR, MS, dimension testing.
• Project coordination (timelines and deliverables are visible and maintained in planning tools), in collaboration with Program Manager
• Implementing the testing strategy (evaluation of method performance, suitability, control strategy, specifications setting)
• Maintaining up-to-date knowledge of assigned projects (molecules, formulation, product presentation)
• Author for quality records and cGMP documents e.g. procedures (SOPs) or source documents, reports, deviations, change requests etc.
• Acting as regulatory liaison for QC in collaboration with the Lonza regulatory expert team
• Participate as Subject Matter Expert in internal and external audits, customer visits and inspections
• Supporting draft of proposals and manufacturing contracts (SoWs)
• Driving a lean mindset and establish mechanisms for continuous improvement

Key requirements: 

• Relevant experience in pharmaceutical industry, preferred with Academic degree in life sciences, e.g. Analytical Chemistry or Biochemistry  
• Excellent working knowledge in relevant analytical techniques related to testing of drug products, specifically Antibody Drug Conjugates.
• Solid knowledge of good manufacturing practices (GMPs) and Profound knowledge in corresponding regulations,  qualification/validation,  compliance systems (e.g. ICH guidelines, PIC/s, USP, EP, JP, PMDA, EMA)
• Strong analytical and problem-solving skills 
• Substantial experience in Quality Control and project management in pharmaceutical industries and cGMP controlled environment
• Ability to effectively prioritize and direct tasks in a fast-paced environment
• Excellent communication skills, command of English, academic writing 

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.