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
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.
About us
The Medicines Manufacturing Centre (MMC) is a brand-new, purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. This cutting-edge centre is part of the North East and North Cumbria Provider Collaborative and has been establishedto meet the growing need for high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products.
Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, particularly for oncology and other high-risk therapies, while creating skilled jobs and driving innovation across the region. The facility is designed to 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 from day one.
Quality, patient safety, and staff wellbeing are at the heart of everything we do. Our leadership team is committed to building a culture of openness, learning, and continuous improvement--offering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit.
Working at the MMC means being part of a forward-thinking and supportive team focused on enabling frontline clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.
Job description
Job 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
Job description
Job 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
Person Specification
Qualifications
Essential
- Degree or equivalent in a scientific subject e.g. microbiology.
Desirable
- Postgraduate qualification in pharmaceutical microbiology or quality control or quality assurance.
- Eligible to be Registered Professional with the General Pharmaceutical Council (GPhC), Health and Care Professions Council HCPC, Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB), or Royal Pharmaceutical Society (RPS).
Experience
Essential
- Good knowledge of microbiological testing techniques used in pharmaceutical quality control.
- Strong technical and analytical skills, with expertise in system risk assessments and validation.
- Experience of working in a microbiological laboratory.
- Familiarity with laboratory safety requirements. e.g. HSE, COSHH.
Desirable
- Experience of microbiology testing techniques as per British Pharmacopoeia requirements and qualification of these methods.
- Knowledge of EU 'Good Manufacturing Practice', including Annex 1.
- Demonstrated knowledge of pharmaceutical microbiology and its application in a GMP environment.
- Experience of using Pharmaceutical Quality Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management.
- Experience in line management
- Knowledge of or experience in Quality improvement tools, techniques and methods.
- Knowledge of or experience in coaching and mentoring practices and tools.
Person Specification
Qualifications
Essential
- Degree or equivalent in a scientific subject e.g. microbiology.
Desirable
- Postgraduate qualification in pharmaceutical microbiology or quality control or quality assurance.
- Eligible to be Registered Professional with the General Pharmaceutical Council (GPhC), Health and Care Professions Council HCPC, Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB), or Royal Pharmaceutical Society (RPS).
Experience
Essential
- Good knowledge of microbiological testing techniques used in pharmaceutical quality control.
- Strong technical and analytical skills, with expertise in system risk assessments and validation.
- Experience of working in a microbiological laboratory.
- Familiarity with laboratory safety requirements. e.g. HSE, COSHH.
Desirable
- Experience of microbiology testing techniques as per British Pharmacopoeia requirements and qualification of these methods.
- Knowledge of EU 'Good Manufacturing Practice', including Annex 1.
- Demonstrated knowledge of pharmaceutical microbiology and its application in a GMP environment.
- Experience of using Pharmaceutical Quality Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management.
- Experience in line management
- Knowledge of or experience in Quality improvement tools, techniques and methods.
- Knowledge of or experience in coaching and mentoring practices and tools.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
