Project Lead Phys-chem Qc 80-100%

vor 3 Wochen

Basel, Schweiz Lonza Vollzeit

Switzerland, BaselToday, 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**:

- Lead and manage pharmaceutical development projects within QC from various customers and in different clinical development phases up to market authorization readiness.
- Accountable for the successful delivery of QC work-packages for assigned projects. This includes on time close out/authorization and provision of required documents and reports (e.g. validation, stability), LIMS specifications, lead of change requests, CAPAs, investigation of deviation and OOX events, representing QC in internal project meetings and customer meetings for highly complex topics as SME (Subject Matter Expert).
- Develop up-to-date knowledge of analytical methods for assigned projects, e.g. HPLC (SEC, IEC, HIC, surfactant content) and CE/icIEF purity methods, protein content, identity (e.g. pepmap), color, clarity, pH, osmolality, extractable volume, CCI, visual inspection, subvisible particles etc.
- Ensure analytical testing and reporting timelines are met, risks made visible e.g. drug product batch releases
- Maintain the cGMP quality standard for assigned processes in PC QC according to applicable SOPs and current health authority/international guidelines (e.g. EMA, FDA CFR, USP, PhEur, JP, PIC/S, ICH).
- Effectively network and liaise with partner units and relevant stakeholders within the Lonza network to ensure the successful delivery of projects.

**Key requirements**:

- MSc or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Extensive working experience in Analytics or Quality Control, preferably under cGMP regulations
- Experience with analytical lifecycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization desired
- Good working knowledge in majority or excellent working knowledge in some of the relevant analytical techniques
- Very good communication & interpersonal skills (matrix leadership), Proactive attitude, detail oriented
- Business fluent English, written and spoken

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.

**Reference: R57188**:

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