QC Scientist

R&D Partners; Shannon; In loco; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• Requires BSc or equivalent in a related scientific discipline.

Mansioni

• 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.

Formazione

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

Strumenti

qPCR

HPLC

Western Blot

SDS-PAGE

DNA extraction

Spectrophotometry

Descrizione del lavoro

R&D Partners is recruiting for a QC Scientist to join a growing biopharmaceutical organisation supporting the manufacture and release of advanced biologic and gene therapy products within a GMP-regulated environment. This role offers the opportunity to work with a broad range of analytical techniques whilst supporting routine testing, method transfers, equipment qualification, and quality compliance activities.

*Please note that to be considered for this role you must currently live, and have the right to work in this country*

Key Responsibilities

• 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 the testing of biologic and gene therapy products, ensuring analytical results are generated and reported accurately and in accordance with GMP requirements.
• Execute and support equipment qualification, assay validation, method transfer and method verification activities within the QC laboratory.
• Maintain laboratory equipment, ensuring calibration, routine maintenance and suitability for use in line with testing schedules.
• Investigate OOS results, deviations and non-conformances, supporting CAPAs, change controls and continuous improvement initiatives.
• Review and maintain GMP documentation including SOPs, laboratory records and quality system documentation whilst ensuring data integrity and GDP compliance.

Experience & Professional Background

• BSc or equivalent qualification in Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemistry, Molecular Biology or a related scientific discipline.
• Proven years working experience working within a GMP-regulated pharmaceutical, biotechnology, biologics or advanced therapeutics environment.
• Hands‑on qPCR experience is essential, alongside practical experience with techniques such as HPLC, Western Blot, SDS‑PAGE, DNA extraction and spectrophotometry.
• Proven experience supporting the testing of large‑molecule, biologics, gene therapy, cell therapy, vaccine or other advanced therapeutic products.
• Experience with analytical method transfer, equipment qualification, assay validation and routine QC testing activities.
• Experience with mammalian cell culture and/or flow cytometry would be advantageous but is not essential.

For more information, please contact Timi Asseez.