QC Scientist - Biologics & Gene Therapy (GMP)

R Dpartners; Missouri; On-site; USD 60,000 - 90,000; Full time

Job summary

R Dpartners is seeking a Quality Scientist to join a growing biopharmaceutical organisation supporting the manufacture and release of advanced biologic and gene therapy products within a GMP-regulated environment. The role covers routine testing, method transfers, equipment qualification, and quality compliance activities.

The candidate will work with qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction and spectrophotometry to generate accurate analytical data and maintain GMP documentation.

Qualifications

• BSc or equivalent qualification in Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemistry, Molecular Biology or related field.
• GMP/GDP and data integrity knowledge within regulated environment.
• Hands-on QC data analysis and attention to detail.

Responsibilities

• Perform routine QC testing for in-process, stability and batch release activities using qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction and spectrophotometry.
• Support testing of biologic and gene therapy products and ensure results are accurate and GMP-compliant.
• Execute and support equipment qualification, assay validation, method transfer and method verification in QC lab.
• Maintain laboratory equipment with calibration and preventive maintenance per testing schedules.
• Investigate OOS results, deviations and non-conformances; support CAPAs and change controls.
• Review GMP documentation including SOPs and records ensuring data integrity.

Job description

R Dpartners is seeking a Quality Scientist to join a growing biopharmaceutical organisation supporting the manufacture and release of advanced biologic and gene therapy products within a GMP-regulated environment. The role covers routine testing, method transfers, equipment qualification, and quality compliance activities.

The candidate will work with qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction and spectrophotometry to generate accurate analytical data and maintain GMP documentation.