(Senior) Scientist QC 80-100%

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Dynamic culture

Inclusive workplace

Recognition programs

Lifestyle benefits

Zusammenfassung

Lonza in Stein, AG, Switzerland, seeks a QC Lab Technician to join a site-based team for release and stability testing of analytical methods (ELISA, HPLC, iCIEF, UV-VIS, CE-SDS). You will validate and transfer methods to enable new projects under cGMP.

You will document results under GDP, calibrate equipment, maintain 6S and assist with equipment upkeep. Fluent English is required; German is a plus.

Qualifikationen

• Solid work experience in Quality Control in GMP environment.
• Experience with analytical methods (ELISA, HPLC or iCIEF) is required.

Aufgaben

• Execute, coordinate and review physico-chemical and biochemical Drug Product release and stability testing under cGMP according to SOPs.
• Document assay execution under cGMP following GDP and flag observations.
• Support validation and transfer activities for new projects.

Jobbeschreibung

Switzerland, Stein

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Be part of an exciting growth project where you’ll contribute to set up a new QC lab! Routine analysis of a large variety of release and stability tests will be the majority of the work. However, besides the routine analysis you will also execute method validation and transfer activities of various physico-chemical methods in order to facilitate implementation. Check out Your Career in Drug Product Services at Lonza !

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What You Will Get

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

The full list of our global benefits can be found at https://www.lonza.com/careers/benefits

What You Will Do

• Ensuring the release of life saving medicines by executing, coordinating and reviewing physico-chemical and biochemical Drug Product release and stability testing under cGMP according to existing method SOPs (e.g. compendial testing/content/identity/purity for biologics/large molecules) – methods used: ELISA, HPLC, iCIEF, UV-VIS, CE-SDS and many others.
• Responsible to document assay execution under cGMP following Good Documentation Practices (GDP) and flag relevant observations to the supervisor for further assessment
• Accountable for execution of operational tasks in the lab, e.g. mobile phase preparations, calibration of equipment, adherence to and maintenance of 6S, consumable management and support of equipment maintenance.
• Support of validation and transfer activities in frame of new project introductions.
• Contribution to investigation/troubleshooting for assigned tasks
• Support in authoring of cGMP documents e.g. procedures (SOPs) or quality records (e.g. OOE/OOS records, CAPA`s)

What We Are Looking For

• Solid work experience in Quality Control in the GMP controlled environment
• Solid hands‑on experience with either ELISA or HPLC or iCIEF is a must (experience with multiple methods is preferred)
• Experience in analytical method validation and method transfer is a plus
• Apprenticeship as Lab technician, Bachelor, Master or equivalent in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
• Knowledge of lab quality systems like LIMS, Tiamo or CDS like Empower/Chromeleon
• Fluency in written and spoken English is a must, German is an asset
• Ability to work independently and in a dynamic & fast‑pacing project environment. Proactive attitude

Reference: R77599