Senior Scientist, Quality Control

Vor 2 Tagen

Luzern, Schweiz MSD Malaysia Vollzeit
Senior Scientist, Quality Control (m/f/d)

We are offering an attractive position for a Senior Scientist, Quality Control (m/f/d) 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. As an active member of our global bioanalytical development team, you will work with your counterparts at our US research sites to apply state-of-the-art technology to support biotechnology process development.

The integrated Biologics Analytical Department provides support to the Biotechnology Department by performing release and stability testing of biological drug substances and is supporting global outsourcing of analytics for biologics, followed by study and quality monitoring to guarantee adherence to regulatory requirements and internal guidelines. Furthermore, the department conducts raw-/starting material and in-process testing for biological drug substances. The position offers development potential; responsibilities can be adjusted to the candidate’s qualifications and ambitions.

Your main accountabilities include:

  • First time establishment of new ELISAs and transfer to CRO and commercialization laboratories.
  • Performing analytical method qualification and method bridging in the laboratory including strategy development and alignment with global company requirements.
  • Release and stability testing of biologics to determine relative biological potency.
  • Second Scientist Review of analytical release and stability data in electronic laboratory notebooks.
  • Writing technical protocols, reports, Standard Operating Procedures (SOPs), etc.
  • Representing the area as a subject matter expert in global development teams.
  • Supporting the local and global department strategies and initiatives.
  • Supporting ELISA lab investigations, change controls, deviations.

Qualifications:

  • Ph.D. in Biochemistry/Chemistry/Biological Sciences, Master’s degree with 3+ years of industry experience, or a Bachelor’s degree with 7+ years of experience.
  • Hands-on experience with ELISAs for biological potency determination.
  • Work experience in a GMP laboratory.
  • Experience with analytical method qualification/validation and method transfer.
  • Experience in protein biochemistry and protein analytics/characterization.
  • Strong oral and written communication skills in English and German.
  • Strong team player, demonstrating mutual respect.
  • Experience in the field of residual host cell protein analysis, residual protein A analysis or critical reagent management is beneficial.

Do you find yourself in the description and are you interested in taking this opportunity? Please send us your complete application documents and become part of a modern company with attractive working conditions.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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