Lab Support Scientist in a QC Chromatography Lab
QLS are recruiting for a Scientist II in QC Chromatography to join an Global Pharmaceutical company on a contract basis for one year.
Company:
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 canbe adjusted to the candidate’s qualifications and ambitions.
Your main accountabilities include:
• Second Scientist Review of analytical release and stability data in electronic laboratory notebooks and LIMS.
• Initiating and supporting laboratory investigations in SAP and writing investigation reports.
• Authoring and Reviewing documents, e.g. technical protocols, reports, Standard Operating Procedures (SOPs).
• Authoring and supporting analytical change controls for method updates and shelf life re-evaluation of clinical batches.
• Performing periodic reviews and authoring review reports for SOPs.
• Close cooperation with program managers and lab heads to align on team priorities and time lines.
• Analytical testing for release, stability and method qualification is an option dependent on business needs and candidate qualification.
Qualifications:
• Master’s degree in Biochemistry/Chemistry/Pharmaceutics/Biological Sciences or similar field, or a Bachelor’s degree/Laboratory Technician EFZ with 3+ years of industry experience.
• Deep knowledge of protein biochemistry and hands on experience with chromatography methodologies.
• Experience in technical writing and document authoring in English.
• Experience in performing formal analytical data reviews.
• Preferably experience with change controls, deviation management and document authoring.
• Industry experience in a GMP environment is strongly preferred.
• Strong oral and written communication skills in English and German.
• Strong team player, demonstrating mutual respect.
• Strong organizational skills and ability to prioritize.
Apply:
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 56515 in all correspondence.
