GMP QC Scientist - Biologics & Gene Therapy

R&D Partners; Shannon; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

R&D Partners is seeking a QC Scientist to join a growing biopharmaceutical organisation in a GMP-regulated environment. You will perform routine QC testing and support method transfers, equipment qualification, and quality compliance activities.

The role offers the opportunity to work with qPCR, HPLC, Western Blot, SDS-PAGE, and DNA extraction as part of routine testing and release activities for advanced biologic products.

Qualifikationen

• Requires BSc or equivalent in a related scientific discipline.

Aufgaben

• Perform routine QC testing to support in-process, stability and batch release activities using techniques including qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction and spectrophotometry.
• Support testing of biologic and gene therapy products, ensuring analytical results meet GMP requirements.
• Execute and support equipment qualification, assay validation, method transfer and method verification in the QC lab.
• Maintain laboratory equipment, calibration and maintenance aligned with testing schedules.
• Investigate OOS results, deviations and non-conformances, supporting CAPAs and change controls.
• Review GMP documentation including SOPs and quality system documentation to ensure data integrity and GDP compliance.

Ausbildung

BSc or equivalent qualification in Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemistry, Molecular Biology or related discipline

Tools

qPCR

HPLC

Western Blot

SDS-PAGE

DNA extraction

Spectrophotometry

Jobbeschreibung

R&D Partners is seeking a QC Scientist to join a growing biopharmaceutical organisation in a GMP-regulated environment. You will perform routine QC testing and support method transfers, equipment qualification, and quality compliance activities.

The role offers the opportunity to work with qPCR, HPLC, Western Blot, SDS-PAGE, and DNA extraction as part of routine testing and release activities for advanced biologic products.