Quality Control Scientist

vor 21 Stunden


Luzern, Schweiz MSD Switzerland Vollzeit

We are looking for a scientist with a strong technical background and hands-on experience in biochemical analytical methods to join our Biologics Analytical Department located in Lucerne/Schachen, Switzerland. You will be part of a multidisciplinary team and support the development of novel biopharmaceuticals.

The Biologics Analytical Department provides support to the manufacturing sites of the company by performing release and stability testing of clinical batches and acting as the interface between method development and validation. We are establishing and validating methods for testing of biologics drug substances and drug products adhering to regulatory GMP requirements.

Main areas of responsibility include:

  • Establishing and running chromatography methods for release & stability testing of Biologics.
  • Careful documentation of lab work following cGMPs and applying good documentation practices.
  • Performing method validation experiments according to approved protocols.
  • Authoring of methods and technical protocols and reports.
  • Improvement of methods and troubleshooting around equipment and procedures.
  • Maintenance and calibration of analytical equipment following cGMPs.

Educational requirements:

  • Master’s degree in Biochemistry/Chemistry/Pharmaceutics/Biological Sciences or similar field, or
  • Bachelor’s degree/Laboratory Technician EFZ with 3+ years of industry experience.

Experience and skills:

  • Deep knowledge of protein biochemistry and hands-on experience with analytical testing by HPLC/UPLC methods, e.g. Size Exclusion, Ion Exchange, Reverse Phase, HIC.
  • Detailed knowledge of a relevant CDS (e.g. Empower).
  • Ability to pipette small volumes precisely and prepare a large number of samples.
  • Accurate working and documentation style with adherence to details.
  • Analytical method validation and GMP working experience is preferred.
  • Excellent oral and written communication skills in English and German.

Please note this is a temporary position; more information will be provided upon application.

Seniority level

Not Applicable

Employment type

Temporary

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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