Quality Control Senior Scientist Microbiology

Northumbria Healthcare NHS Foundation Trust; Seaton; On-site; GBP 30,000 - 45,000; Full time

Job summary

An exciting opportunity for a QC Scientist Microbiology to join a pioneering NHS pharmaceutical facility in Seaton Delaval. This role involves leading a team, ensuring quality standards, and developing microbiological processes in a supportive environment focused on patient care.

Qualifications

• Knowledge of microbiological testing techniques and experience in a microbiological lab.
• Familiarity with safety standards such as HSE, COSHH.

Responsibilities

• Lead and train QC Microbiology Technicians in testing techniques.
• Perform method development and analytical validation for QC testing.
• Conduct sterility testing and ensure compliance with GMP standards.

Skills

Microbiological Testing Techniques

Leadership

Quality Control

Education

Degree in a Scientific Subject

Postgraduate Qualification in Pharmaceutical Microbiology

Job description

Job summary

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

1. Lead and train Quality Control (QC) Microbiology Technicians, ensuring they are proficient in microbiological testing techniques and maintain high standards of performance.
2. Perform method development and analytical method validation for microbiological QC testing techniques to ensure regulatory compliance and quality standards.
3. Conduct sterility testing on-site in a dedicated sterility testing isolator, ensuring adherence to protocols and GMP standards.
4. Demonstrate and perform microbiological identification techniques, including the use of advanced equipment such as MALDI-TOF mass spectrometry.
5. Perform media fertility testing (growth promotion) and manage local isolates and bioburden studies to ensure the effectiveness of microbiological testing methods.
6. Demonstrate and ensure compliance with cleanroom behaviours such as gowning, cleaning, transfer disinfection, daily monitoring, and proper documentation in line with regulatory standards.
7. 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.
8. Develop and produce essential documentation such as Standard Operating Procedures (SOPs), worksheet designs, and training materials, ensuring compliance with GMP and data integrity standards.

About us

The Medicines Manufacturing Centre (MMC) is a purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. It aims to meet the growing need for high-quality, regionally manufactured medicines, supporting a secure supply chain for critical therapies like oncology medicines, funded with £30 million from NHS England.

The MMC will operate under a Manufacturer's Specials Licence (MS) and aims to secure a Wholesale Dealer's Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations. Our core values include quality, patient safety, and staff wellbeing, fostering a culture of openness, learning, and continuous improvement.

Working at the MMC provides an opportunity to be part of a forward-thinking, supportive team dedicated to enabling clinical staff to focus more on patient care by delivering safe, ready-to-use medicines.

Job description

Job responsibilities

• Assist in developing microbiological processes, equipment qualification and maintenance, and documentation control/reviews. Ensure data integrity, proper data recording, trending, and statistical analysis.
• Manage the supplier approval process for microbiology-related materials used in the MMC, ensuring all materials meet quality standards.
• Oversee the ordering and receipt of QC materials, managing stock and resource availability.
• Ensure proper storage of reagents and media, managing inventory and expiration dates.
• Ensure QC microbiology equipment is qualified, serviced, and maintained in good condition.
• Model compassionate and inclusive leadership, engaging and empowering team members, promoting ownership of learning and quality improvement, and facilitating cross-department collaboration.

Person Specification

Qualifications

• Essential: Degree or equivalent in a scientific subject, e.g., microbiology.
• Desirable: Postgraduate qualification in pharmaceutical microbiology, quality control, or quality assurance; registration with GPhC, HCPC, RSC, RSB, or RPS.

Experience

• Essential: Knowledge of microbiological testing techniques, experience in a microbiological lab, familiarity with safety standards such as HSE, COSHH.
• Desirable: Experience with British Pharmacopoeia methods, EU GMP, pharmaceutical microbiology in GMP environments, pharmaceutical quality systems, leadership, and coaching skills.

Additional information

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975, requiring a DBS check. Applicants needing Skilled Worker sponsorship are welcome; further details available on the respective websites. Applicants must present a criminal record certificate from countries of residence over the past 10 years if applicable.

Employer details

Employer name: Northumbria Healthcare NHS Foundation Trust

Address: Medicines Manufacturing Centre, Manufacturing and Innovation Hub, Avenue Road, Seaton Delaval, NE25 0QJ

Employer's website: [Insert URL]