QC PL PPQ readiness 80-100%
Vor 3 Tagen
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.
Key Responsibilities:
Represent Lonza in internal and customer meetings as project champion Enable release and stability testing of late phase (PPQ and Commercial) Drug Product (MABs, ADC, mRNA) within Lonza QC by: Project coordination (timelines and deliverables are visible and maintained in planning tools), in collaboration with Program Manager Defining the testing strategy (evaluation of method performance, suitability, control strategy, specifications setting) Acting as regulatory liaison for QC in collaboration with the Lonza regulatory expert team Leading discussions with customers and interface with SMEs Ensuring the e.g. Bio-Chemical testing, Physico-Chemical testing, Forensic Chemistry, Microbiology, incoming goods control, manufacturing, MSAT (Manufacturing, Science & Technologies), QA, Regulatory) Supporting draft of proposals and manufacturing contracts (SoWs) Maintaining up-to-date knowledge of assigned projects (molecules, formulation, product presentation) 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. Adhere to cGMP regulations QC Project SME for audits and inspectionsKey Requirements:
Degree in Life science or management (Bachelor, Master, Ph.D., MBA or similar) Scientific and GMP experience, commercial and financial acumen Strong analytical and problem-solving skills Substantial experience in QC, project management, QA or similar Results oriented and able to prioritize workload to meet timelines Knowledge of pharmaceutical regulatory landscape (e.g. ICH guidelines, PIC/s, US FDA, PMDA, EMA) Excellent communication skills, command of English, academic writingEvery 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.
Reference: R60170-
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