Quality Control Senior Scientist Microbiology

Job overview

An exciting opportunity has arisen for a proactive and passionate QC Scientist Microbiology to join the Medicines Manufacturing Centre (MMC)—a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland. The MMC is in its final design stages, with facility construction planned through to September 2025.

This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.

All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees’ continuity of employment is preserved.

Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.

Main duties of the job

Lead and train Quality Control (QC) Microbiology Technicians, ensuring they are proficient in microbiological testing techniques and maintain high standards of performance.

Perform method development and analytical method validation for microbiological QC testing techniques to ensure regulatory compliance and quality standards.

Conduct sterility testing on-site in a dedicated sterility testing isolator, ensuring adherence to protocols and GMP standards.

Demonstrate and perform microbiological identification techniques, including the use of advanced equipment such as MALDI-TOF mass spectrometry.

Perform media fertility testing (growth promotion) and manage local isolates and bioburden studies to ensure the effectiveness of microbiological testing methods.

Demonstrate and ensure compliance with cleanroom behaviours such as gowning, cleaning, transfer disinfection, daily monitoring, and proper documentation in line with regulatory standards.

Complete relevant PQS elements, including microbiological Out of Specification (OOS) investigations, Root Cause Analysis (RCA), and Quality Risk Management (QRM) to ensure continuous improvement and regulatory compliance.

Develop and produce essential documentation such as Standard Operating Procedures (SOPs), worksheet designs, and training materials, ensuring compliance with GMP and data integrity standards.

Detailed job description and main responsibilities

Assist in the development of microbiological processes, equipment qualification and maintenance, and documentation control/reviews. Ensure data integrity and proper data recording, trending, and statistical analysis.

Manage the supplier approval process for microbiology-related materials used in the MMC cleanroom facility and laboratories, ensuring all materials meet necessary quality standards.

Oversee the ordering and receipt of QC materials, ensuring proper stock management and availability of necessary resources for testing.

Ensure the proper storage of reagents and media, managing inventory and expiration dates to maintain operational efficiency.

Ensure QC microbiology equipment is properly qualified, serviced, and maintained to remain in good operational condition.

Role model compassionate and inclusive leadership, shaping a collective leadership culture within the trust. This includes:

• Engaging, enabling, and empowering team members Using coaching techniques to promote ownership of learning and quality improvement Facilitating teamwork and collaboration across departments and organisational boundaries
• Engaging, enabling, and empowering team members
• Using coaching techniques to promote ownership of learning and quality improvement
• Facilitating teamwork and collaboration across departments and organisational boundaries