QC Scientist

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

Are you looking for your next challenge within quality control where you can work within biopharmaceuticals?

R&D Partners is recruiting for 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. 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 have the right to work in this location

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.

Key Competencies

• Strong understanding of GMP, GDP and Data Integrity requirements within a regulated pharmaceutical or biotechnology environment.
• Excellent analytical and problem-solving skills with the ability to investigate trends, anomalies and laboratory issues effectively.
• High attention to detail with a commitment to delivering accurate, high-quality analytical data.
• Strong organisational skills with the ability to manage multiple priorities in a fast-paced environment.
• Effective written and verbal communication skills, including technical documentation and cross-functional collaboration.
• Proactive mindset with a continuous improvement approach and willingness to learn new systems, technologies and laboratory techniques.

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.

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