Vor 10 Stunden veröffentlicht

Project Lead Phys-Chem QC 80-100% (f/m/d)

Project Lead Phys-Chem QC 80-100% (f/m/d)

Project Lead Phys-Chem QC 80-100% (f/m/d)

Project Lead Phys-Chem QC 80-100% (f/m/d)

Lonza AG

Bio- und Nanotechnologie

Basel

  • Art der Anstellung: Vollzeit
  • 104.500 CHF – 139.500 CHF (von XING geschätzt)
  • Vor Ort
  • Zu den Ersten gehören

Project Lead Phys-Chem QC 80-100% (f/m/d)

Über diesen Job

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 DPS (Drug Product Services) in Basel Switzerland, we have an open position for a project scientist in our growing team. Working closely with Physico-Chemical and Quality Control, this team offers specialized services solutions for customers. Become part of this exciting opportunity by applying for the position of Project Lead Phys-Chem and join this outstanding team!

What you’ll get:

  • An agile career and a dynamic work culture

  • An inclusive and ethical workplace

  • Compensation programs that recognize high performance

What you’ll do:

  • Lead and manage pharmaceutical development projects within QC from various customers and in different clinical development phases up to 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.

  • 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 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.

What we're looking for:

  • MSc or PhD or equivalent experience in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field

  • Proven 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

  • Very good communication & interpersonal skills, team mentality and 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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color , national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

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