(Senior) Scientist QC 80-100%

Lonza; Stein (AR); Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Performance pay

Lifestyle benefits

Zusammenfassung

Lonza in Stein, Switzerland seeks a Quality Control professional to join a site-based team responsible for release and stability testing of Drug Products. You will execute and review physico-chemical and biochemical assays, support method validation and transfers, and maintain GDP and 6S standards in a fast-paced lab environment.

Ideal candidates have solid GMP QC experience, hands-on ELISA/HPLC/iCIEF skills, and a background in Analytical Chemistry or related fields.

Qualifikationen

• Solid work experience in Quality Control within GMP environments.
• Hands-on experience with ELISA, HPLC or iCIEF (multiple methods preferred).
• Experience in analytical method validation and transfer is a plus.
• Apprenticeship as Lab technician or degree in Analytical Chemistry/Biochemistry/Pharmaceutical Sciences.
• Knowledge of LIMS, Tiamo or CDS ( Empower/Chromeleon ).
• Fluent in English; German is an asset.
• Ability to work independently in a dynamic, fast-paced project environment.

Aufgaben

• Release of medicines by executing and reviewing physico-chemical and biochemical tests under cGMP.
• Document assay execution following Good Documentation Practices (GDP).
• Perform operational lab tasks: mobile phase prep, equipment calibration, 6S, consumables management.
• Support validation and transfer activities for new projects.
• Contribute to investigations and troubleshooting.
• Assist in authoring cGMP documents and quality records (SOPs, CAPA, OOE/OOS).

Kenntnisse

Quality Control experience

cGMP

Documentation & GDP

6S / housekeeping

Independent work

Ausbildung

Lab technician apprenticeship or degree in Analytical Chemistry/Pharmaceutical Sciences

Tools

ELISA

HPLC

iCIEF

Jobbeschreibung

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.

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.

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

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.