Job summary
An exciting opportunity has arisen for a proactive and passionate Site Microbiologist 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. Initially, staff will be employed by Northumbria Healthcare Foundation NHS Trust, with employment transferring to the Medicines Manufacturing Centre Legal Liability Partnership (LLP) upon its formation under TUPE regulations.
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.
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 established to meet the growing need for high-quality, regionally manufactured Ready-to-Administer medicines and advanced aseptic products.
Main duties of the job
Key Responsibilities:
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Lead and maintain the site Environmental Monitoring plan.
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Oversee the Contamination Control Strategy (CCS), providing microbiological expertise on production processes and quality risk assessments.
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Review and analyse environmental monitoring and QC microbiology laboratory data, producing annual reports.
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Support new product introduction with microbiological insights, including product specifications and testing requirements.
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Contribute to pharmaceutical quality systems (PQS) in areas such as OOS, deviations, root cause analysis, and microbiological non-conformances.
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Lead and manage the QC microbiology laboratory and sterility testing cleanroom suite, ensuring compliance with testing requirements.
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Foster a collaborative, compassionate leadership culture by engaging, enabling, and empowering teams across the organisation.
About us
We manage three major locality hospitals at North Tyneside, Wansbeck and Hexham, plus a number of smaller community hospitals and clinics from Tynemouth to Berwick on Tweed, in addition to our state-of-the-art Northumbria Specialist Emergency Care Hospital, the first of its kind in England. We also care for people in their homes and provide services from facilities in local communities such as health centres.
We give people greater choice and control over their care to help them to live independently at home and avoid hospital admission where appropriate.High quality patient care is at the heart of everything we do and we strive to ensure every single patient and service user has an exceptional experience with us. We have one of the most extensive patient experience programmes of any trust in England.
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. It's more than a job--it's a chance to contribute behind the scenes to better, safer healthcare for all.
Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, while creating skilled jobs and driving innovation across the region.
Job description
Job responsibilities
Job description attached separately
At the MMC, 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 improvementoffering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit.
The facility is designed to operate under a Manufacturers Specials Licence (MS) and aims to secure a Wholesale Dealers Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one.
Job description
Job responsibilities
Job description attached separately
At the MMC, 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 improvementoffering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit.
The facility is designed to operate under a Manufacturers Specials Licence (MS) and aims to secure a Wholesale Dealers Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one.
Person Specification
Qualifications
Essential
- Degree in a scientific discipline e.g. Microbiology
- Eligibility to register with a Professional Body for example: General Pharmaceutical Council (GPhC), the Health and Care Professions Council (HCPC), Royal Society for Biology (RSB), Royal Society for Chemistry (RSC), or Royal Pharmaceutical Society (RPS).
Desirable
- Post graduate qualification e.g. pharmaceutical microbiology
- Professional registration
- Management qualification
Experience
Essential
- Significant demonstrable post qualification experience as a subject matter expert in pharmaceutical microbiology within sterile manufacturing
- Highly Specialist Pharmaceutical Microbiology Professional requires detailed current knowledge of: MHRA Guide to Good Manufacturing Practice, and the requirements as per Annex 1 for the role of a site microbiologist. Knowledge of sterile manufacture, in accordance with GMP (Annex 1).
- Experience in Microbiology QC testing and method validation requirements e.g. environmental plates reading, Microorganism Identification techniques, media growth promotion tests, sterility testing, bioburden.
- Experience in environmental monitoring programmes and contamination control strategy for pharmaceutical manufacturing areas (grade A to CNC).
- Experience of using Pharmaceutical Quality Systems, including, leading microbiological non-conformances, root cause analysis tools, change controls, out-of-specifications, quality risk management, document management.
- Knowledge in trending and statistical analysis of data.
- Evidence of successfully managing a team.
Desirable
- Management of a sterility testing suite
- Knowledge of technical areas of pharmacy, including pharmaceutical manufacturing, procurement, auditing and unlicensed medicines.
- Experience in management of QC data integrity requirements and improvements.
- Evidence of participating within an MHRA Regulatory inspection
- Awareness of national policies and best practices which impact on role.
Person Specification
Qualifications
Essential
- Degree in a scientific discipline e.g. Microbiology
- Eligibility to register with a Professional Body for example: General Pharmaceutical Council (GPhC), the Health and Care Professions Council (HCPC), Royal Society for Biology (RSB), Royal Society for Chemistry (RSC), or Royal Pharmaceutical Society (RPS).
Desirable
- Post graduate qualification e.g. pharmaceutical microbiology
- Professional registration
- Management qualification
Experience
Essential
- Significant demonstrable post qualification experience as a subject matter expert in pharmaceutical microbiology within sterile manufacturing
- Highly Specialist Pharmaceutical Microbiology Professional requires detailed current knowledge of: MHRA Guide to Good Manufacturing Practice, and the requirements as per Annex 1 for the role of a site microbiologist. Knowledge of sterile manufacture, in accordance with GMP (Annex 1).
- Experience in Microbiology QC testing and method validation requirements e.g. environmental plates reading, Microorganism Identification techniques, media growth promotion tests, sterility testing, bioburden.
- Experience in environmental monitoring programmes and contamination control strategy for pharmaceutical manufacturing areas (grade A to CNC).
- Experience of using Pharmaceutical Quality Systems, including, leading microbiological non-conformances, root cause analysis tools, change controls, out-of-specifications, quality risk management, document management.
- Knowledge in trending and statistical analysis of data.
- Evidence of successfully managing a team.
Desirable
- Management of a sterility testing suite
- Knowledge of technical areas of pharmacy, including pharmaceutical manufacturing, procurement, auditing and unlicensed medicines.
- Experience in management of QC data integrity requirements and improvements.
- Evidence of participating within an MHRA Regulatory inspection
- Awareness of national policies and best practices which impact on role.
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).
