Job summary
- Main area
- Medicines Manufacturing Centre - Research and Development
- Grade
- NHS AfC: Band 7
- Contract
- Permanent
- Hours
- Full time
- Flexible working
- Compressed hours
- Job ref
- 319-7168498JN
- Employer
- Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust
- Employer type
- NHS
- Site
- Manufacturing and Innovation Hub
- Town
- Seaton Delaval
- Salary
- £46,148 - £52,809 per annum
- Salary period
- Yearly
- Closing
- 21/05/2025 23:59
Employer heading
QC Validation Scientist
NHS AfC: Band 7
Do you want to work in one of the best performing NHS organisations in England? Work for an organisation that was voted the best acute and combined acute and community trust in the country, based on the experience of its staff (NHS Staff Survey 2022). Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep. Sound too good to be true? Well it isn’t, this is what you get when you work for Northumbria Healthcare and, this is…the Northumbria Way!
What the Northumbria Way means for you:
- Extensive staff health and well-being programme including access to our specialist Wellbeing Hub
- Support and connection through a variety of Staff Network groups
- A range of flexible working opportunities
- Generous annual leave and pension scheme
- Access to lease car and home electronics scheme (qualifying criteria applies)
- Opportunities to improve your professional development through our vast training programmes
- On-site nursery places via salary sacrifice
- Access to savings scheme via salary sacrifice with Northumberland Community Bank
We are proud to be one of the country’s top performing NHS trusts – rated ‘outstanding’ overall by the Care Quality Commission (CQC). We provide a range of health and care services to support more than 500,000 people living in Northumberland and North Tyneside across the largest geographical area of any NHS Trust in England. Our teams deliver care from hospitals, a range of community venues and people’s homes. Our hospitals include a specialist emergency care hospital (the first of its kind in England), three general hospitals and community hospitals. In the community we deliver a wide range of community and public health services.
We lead in innovation and quality, having opened the Northumbria Healthcare Manufacturing and Innovation Hub during the Covid-19 pandemic and have recently launched our Community Promise – a pledge to make a real impact not just in healthcare but on the wider factors that affect people’s lives, such as education, employment and the economy.
If Northumbria Healthcare sounds like somewhere you could belong we would love to hear from you. Visit our website to catch up on our latest news.
Whilst Northumbria Healthcare are a highly innovative organisation, the use of Third Party Artificial Intelligence (AI) presents a risk to the integrity of our Recruitment & Selection processes. If you use AI, and it poses a risk to the integrity your individual recruitment process, we may withdraw your application at any stage of the process.
Job overview
An exciting opportunity has arisen for a proactive and passionate Quality Control Validation Scientist 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
Main duties of the job
Oversee New Product Introduction processes from a QC perspective for products to be manufactured in the Medicines Manufacturing Centre (MMC). This includes:
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Method development (ICH Q14)
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Analytical method validation (ICH Q2)
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Technology/method transfer
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QC stability testing (ICH Q1)
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Ongoing stability studies
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Formulation studies
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Sampling plans
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Cleaning validation (residue testing) methods
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Lead the QC reference standards processes, including:
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Routine use and validation of working standards
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Management of reference and retention samples for finished products and raw materials
Implement QC policies to ensure compliance with Good Manufacturing Practices (GMP).
Support the management of contractors for outsourced QC Chemistry work.
Lead the qualification, planned preventative maintenance (PPM), and servicing of QC chemistry equipment.
Manage the chemistry laboratory staff on a day-to-day basis and for long-term planning. Lead training initiatives for QC scientists in relevant QC methods.
Prepare and implement QC documentation such as:
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Protocols for stability studies, investigational work, and validations
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QC reports, worksheets, SOPs, stability plans
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Statistical analysis
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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 assessments on Change Control
Working for our organisation
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.
Detailed job description and main responsibilities
Perform QC data recording, trending, and statistical analysis for all QC chemistry data, ensuring accuracy and compliance.
Oversee the implementation of stability studies and ongoing stability testing programs, including investigational work and validations.
Ensure analysis of raw materials, packaging components, and finished pharmaceutical products is performed in line with approved QC worksheets and SOPs.
Demonstrate compassionate and inclusive leadership, actively shaping 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
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Person specification
Qualifications
Essential criteria
- Masters degree in relevant scientific discipline or equivalent experience.
- Eligible to be Registered Professional with the General Pharmaceutical Council (GPhC), or Health and Care Professions Council (HCPC), or Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB), or Royal Pharmaceutical Society (RPS).
Desirable criteria
- Professional Registration
- Post graduate qualification in Analytical chemistry / pharmaceutical analysis
- Post graduate qualification in Quality Assurance / GMP
Experience
Essential criteria
- Post qualification experience in the analytical techniques used in pharmaceutical quality control.
- QC Professional requires detailed current knowledge of: MHRA Guide to Good Manufacturing Practice, and the British and European pharmacopeial requirements for raw materials, intermediates, and finished products.
- Knowledge of analytical method validation (ICH Q2).
- Knowledge of developing stability studies as per ICH Q1.
- Knowledge in the qualification, use and maintenance of laboratory instruments including HPLC, FTIR, UV-VIS, pH, balances.
- Knowledge in trending and statistical analysis of data.
- Knowledge and experience in implementing laboratory safety requirements. e.g. COSHH.
Desirable criteria
- Experience of New Production Introduction management from a Quality Control Perspective
- Experience of GMP product formulation studies
- Experience of using Quality Management Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management
- Experience in QC testing requirements of sterile medicines – both chemistry and microbiological specifications, in alignment with pharmacopeial requirements and formulation requirements
- Awareness of developments in technical areas of Pharmaceutical Manufacture.
- Knowledge of or experience in coaching and mentoring practices and tools.
- Knowledge of or experience in Quality improvement tools, techniques and methods.
Employer certification / accreditation badges
Applicant requirements
The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
Documents to download
Further details / informal visits contact
- Name
- Carly McGurty
- Job title
- Deputy Head of Quality
- Email address
- [email protected]
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