Job summary
An exciting opportunity has arisen for a proactive and passionate Quality Control Lead 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
Oversee the New Product Introduction (NPI) processes from a Microbiology QC perspective, ensuring successful implementation for products to be manufactured in the Medicines Manufacturing Centre (MMC). This includes:
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Method development
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Analytical method validation
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Technology/method transfer
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Reference standards management
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Sampling and QC stability testing
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Ongoing stability studies
Supervise QC Microbiology testing for:
Implement QC Microbiology policies and processes that comply with Good Manufacturing Practice (GMP) and data integrity requirements.
Oversee and manage QC Microbiology documentation, ensuring all records are up to date and comply with regulatory requirements.
Lead training for QC Microbiology staff, ensuring they are proficient in relevant QC methods and regulatory standards.
Prepare and implement QC microbiology documentation such as:
Perform assessments for the Pharmaceutical Quality System (PQS), including:
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Out of Specification (OOS) investigations
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Root Cause Analysis (RCA)
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Quality Risk Assessment (QRA)
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QC assessment on Change Control
Perform QC data recording, trending, and statistical analysis for QC microbiology data, and track Key Performance Indicators (KPIs).
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 established to 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.
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 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
Support the implementation of stability studies and ongoing stability testing programs, as well as investigational work and validations.
Ensure that analysis on raw materials, packaging components, and finished pharmaceutical products is carried out in line with approved QC worksheets and SOPs.
Oversee the supplier approval process and manage incoming goods checks and testing.
Develop and manage processes for the Microbiology QC Lab and sterility suite, including workload management and resource allocation.
Manage a team of Microbiology Quality Control Scientists, ensuring their development and performance within the laboratory.
Ensure that all QC microbiology equipment is properly qualified and serviced, including managing contractors for outsourced activities.
Demonstrate compassionate and inclusive leadership, contributing to the creation of a collective leadership culture within the Trust by:
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Engaging, enabling, and empowering others
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Using coaching to promote ownership of learning and quality improvement
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Facilitating team working and collaboration across teams, departments, and organisational boundaries
Job description
Job responsibilities
Support the implementation of stability studies and ongoing stability testing programs, as well as investigational work and validations.
Ensure that analysis on raw materials, packaging components, and finished pharmaceutical products is carried out in line with approved QC worksheets and SOPs.
Oversee the supplier approval process and manage incoming goods checks and testing.
Develop and manage processes for the Microbiology QC Lab and sterility suite, including workload management and resource allocation.
Manage a team of Microbiology Quality Control Scientists, ensuring their development and performance within the laboratory.
Ensure that all QC microbiology equipment is properly qualified and serviced, including managing contractors for outsourced activities.
Demonstrate compassionate and inclusive leadership, contributing to the creation of a collective leadership culture within the Trust by:
-
-
Engaging, enabling, and empowering others
-
Using coaching to promote ownership of learning and quality improvement
-
Facilitating team working and collaboration across teams, departments, and organisational boundaries
Person Specification
Qualifications
Essential
- Degree in relevant scientific discipline or equivalent experience.
- 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).
Desirable
- Professional Registration
- Post graduate qualification in Pharmaceutical Microbiology / pharmaceutical science
- Post graduate qualification in Quality Assurance / GMP
Experience
Essential
- Knowledge of EU Good Manufacturing Practice, including Annex 1
- Demonstrated knowledge of pharmaceutical microbiology and its application in a GMP environment
- Strong technical and analytical skills, with expertise in system risk assessments and validation
- Experience of microbiology testing techniques as per British Pharmacopoeia requirements and qualification of these methods e.g. ID testing, sterility testing, growth promotion, bioburden
- Knowledge in the qualification, use and maintenance of laboratory instruments
- Knowledge in trending and statistical analysis of data.
- Knowledge and experience in implementing laboratory safety requirements. e.g. COSHH.
Desirable
- Experience of New Production Introduction management from a Quality Control Perspective
- Experience of using Pharmaceutical Quality Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management
- Experience in QC micro testing requirements of sterile medicines, in alignment with pharmacopeial requirements and formulation requirements.
- Awareness of developments in technical areas of Pharmaceutical Manufacture.
- Experience of managing a team
- Experience of managing a laboratory
- Knowledge of or experience in coaching and mentoring practices and tools.
- Knowledge of or experience in Quality improvement tools, techniques and methods.
Person Specification
Qualifications
Essential
- Degree in relevant scientific discipline or equivalent experience.
- 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).
Desirable
- Professional Registration
- Post graduate qualification in Pharmaceutical Microbiology / pharmaceutical science
- Post graduate qualification in Quality Assurance / GMP
Experience
Essential
- Knowledge of EU Good Manufacturing Practice, including Annex 1
- Demonstrated knowledge of pharmaceutical microbiology and its application in a GMP environment
- Strong technical and analytical skills, with expertise in system risk assessments and validation
- Experience of microbiology testing techniques as per British Pharmacopoeia requirements and qualification of these methods e.g. ID testing, sterility testing, growth promotion, bioburden
- Knowledge in the qualification, use and maintenance of laboratory instruments
- Knowledge in trending and statistical analysis of data.
- Knowledge and experience in implementing laboratory safety requirements. e.g. COSHH.
Desirable
- Experience of New Production Introduction management from a Quality Control Perspective
- Experience of using Pharmaceutical Quality Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management
- Experience in QC micro testing requirements of sterile medicines, in alignment with pharmacopeial requirements and formulation requirements.
- Awareness of developments in technical areas of Pharmaceutical Manufacture.
- Experience of managing a team
- Experience of managing a laboratory
- Knowledge of or experience in coaching and mentoring practices and tools.
- Knowledge of or experience in Quality improvement tools, techniques and methods.
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).
