Project Lead Clinical Quality Control Physico Chemical Analytics
vor 16 Stunden
Project Lead Clinical Quality Control Physico Chemical Analytics (m/f/d)
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, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Are you ready to become part of a group that enables its customers to meet some of the greatest challenges in patient treatment? Join us by applying for the position as Project Lead Clinical Quality Control Physico Chemical Analytics
Key Responsibilities:- Lead pharmaceutical development projects for drug entities (mAB/protein) at all levels of complexity and new modalities (e.g. ADC, mRNA). Projects will involve QC, different clinical development phases, and market authorization readiness.
- Responsible for timely completion and submission of necessary documents and reports, including stability reports and LIMS specifications. Also leads change requests, CAPAs, and investigations of deviations and OOX events. Represents QC in internal and customer meetings as a subject matter expert.
- Maintain the cGMP quality standard for assigned processes in PhysChem QC according to applicable SOPs and current health authority/international guidelines (e.g. EMA, FDA CFR, USP, PhEur, JP, PIC/S, ICH).
- Coordinate with partner units and Lonza network to reliably deliver projects and implement safety regulations and Key Quality Indicators (KQI).
- MSc or PhD degree in Biochemistry, Pharmaceutics, Chemistry or related field with confirmed work experience in relevant area.
- Previous experience in protein analytics, specifically understanding protein degradation pathways and molecule liabilities. Preferably with a strong track record in a cGMP regulated area of the pharmaceutical or chemical industry, specifically in analytical quality control or Analytical Development of large molecule.
- Over 3 years’ working experience on the analytical lifecycle of biotechnology products, CMC requirements for regulatory filings required.
- Experience in cGMP Quality Control of Antibody-Drug Conjugates (ADC) and/or mRNA, either on Drug Substance and/or Drug Product level, is a strong advantage.
- Hands-on experience in management of quality records like deviations, CAPAs, Change Requests.
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.
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Basel, Basel-Stadt, Schweiz Lonza VollzeitSenior Project Lead Clinical Quality Control Physico Chemical AnalyticsAt Lonza, we are committed to delivering high-quality products and services that make a meaningful difference in people's lives. As a Senior Project Lead Clinical Quality Control Physico Chemical Analytics, you will play a critical role in ensuring the successful delivery of...
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