About this role
Job summary
An exciting opportunity has arisen for a Production Manager to play a key leadership role in the establishment and operation of the Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC is a state-of-the-art NHS facility dedicated to the sterile manufacture of injectable medicinal products.
Operating under MHRA Good Manufacturing Practice (GMP) standards, the MMC is being developed to provide a secure and sustainable supply of Ready-to-Administer (RtA) medicines and Systemic Anti-Cancer Therapy (SACT) products across the North East and North Cumbria.
As Production Manager, you will lead production operations across the facility, ensuring the safe, efficient and compliant manufacture of sterile medicinal products. You will provide operational leadership for manufacturing, warehouse and facility activities, support new product introduction and validation programmes, and contribute to the ongoing development of a modern NHS manufacturing service focused on quality, patient safety and continuous improvement.
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 day-to-day production operations within the MMC, ensuring the manufacture of sterile medicinal products in compliance with MHRA and EU GMP requirements.
- Manage production, warehouse and associated operational teams, ensuring appropriate staffing, training, competency and performance management arrangements are in place.
- Support the commissioning, qualification, maintenance and ongoing compliance of manufacturing facilities, cleanrooms, utilities and production equipment.
- Lead New Product Introduction (NPI) activities, process design and process validation to support the introduction of new medicines and services.
- Ensure effective production planning and capacity management to meet patient and customer demand whilst maintaining quality and compliance standards.
- Work closely with Quality Assurance, Quality Control, Engineering and Supply Chain teams to maintain robust Pharmaceutical Quality Systems and support regulatory inspections.
- Lead investigations, risk assessments, CAPA implementation and continuous improvement activities relating to manufacturing operations.
- Manage contractors and external suppliers involved in production-related activities and equipment support.
- Support budget management, procurement activities and efficient use of resources across manufacturing operations.
- Promote a culture of patient safety, quality, continuous improvement, teamwork and inclusive leadership throughout the organisation.
About us
The Medicines Manufacturing Centre (MMC) is a purpose-built NHS pharmaceutical production facility located within the Northumbria Healthcare Manufacturing and Innovation Hub in Seaton Delaval, Northumberland. The centre has been established to meet the growing regional demand for high-quality Ready-to-Administer (RtA) medicines and advanced aseptic products.
Funded through £30 million of NHS investment, the MMC will strengthen medicine supply resilience across the North East and North Cumbria by manufacturing critical medicines closer to patients. Operating under a Manufacturer's Specials Licence and supporting future commercial growth opportunities, the facility combines modern technology, highly skilled staff and robust pharmaceutical quality systems to deliver safe and effective medicines.
At the MMC, patient safety, quality and continuous improvement are central to everything we do. This is a rare opportunity to join a new organisation at a pivotal stage of development and help shape the future of NHS pharmaceutical manufacturing while working alongside specialists in production, quality, engineering and operational excellence.
Working at the MMC means being part of an ambitious and collaborative team committed to delivering safe medicines, supporting frontline healthcare services and improving outcomes for patients across the region.
Job description
Job responsibilities
- Lead all manufacturing operations within the Medicines Manufacturing Centre (MMC), ensuring the safe, efficient and compliant production of sterile medicinal products in accordance with MHRA and EU GMP requirements.
- Manage production facilities, equipment and operational resources to ensure manufacturing activities are planned, executed and monitored in line with approved procedures and production schedules.
- Lead production readiness, commissioning and operational qualification activities for new facilities, equipment and manufacturing processes in collaboration with Quality Assurance, Engineering and Validation teams.
- Own production planning and capacity management processes to ensure customer demand, service requirements and operational targets are achieved.
- Provide leadership for New Product Introduction (NPI) activities within Production, ensuring successful transfer, implementation and routine manufacture of new products.
- Ensure manufacturing operations are supported by effective investigation, deviation, CAPA and change control processes, driving continuous improvement and operational excellence.
- Work collaboratively with Quality Assurance, Quality Control, Engineering, Procurement and Supply Chain teams to maintain GMP compliance, product quality and supply resilience.
- Manage production-related contractors, suppliers and service providers, ensuring activities are appropriately controlled and delivered to agreed quality and performance standards.
- Lead warehouse and materials management activities, ensuring appropriate control of raw materials, components, consumables and finished products.
- Develop and maintain production performance metrics, monitoring productivity, quality, batch release performance, right-first-time manufacture and operational efficiency.
- Prepare, manage and monitor production budgets, resource plans and staffing requirements to support sustainable operational performance.
- Build, lead and develop the Production team, ensuring appropriate recruitment, training, competency assessment, succession planning and performance management arrangements are in place.
- Deliver training and coaching on manufacturing processes, GMP requirements and operational procedures across the MMC.
- Lead or support site crisis management arrangements, business continuity planning and planned or unplanned production shutdown activities.
- To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the Trust. This means demonstrating a consistent leadership style which
- (a) engages, enables and empowers others
- (b) uses coaching to promote ownership of learning and quality improvement and
- (c) facilitates team working and collaboration within teams, departments and across organisational boundaries.
Person Specification
Qualifications / Professional Registration
Essential
- Master's degree in a scientific discipline or be willing to work towards a Master's degree while in post
- Post-graduate qualification in Pharmaceutical Manufacturing or equivalent experience
- Registered Professional
Desirable
- Postgraduate diploma in Pharmaceutical Technology and Quality Assurance
- Management qualification
Experience and knowledge
Essential
- Significant post qualification experience in Pharmaceutical Manufacturing
Desirable
- Budgetary planning / financial management experience
- Lecturing / Public speaking
Other requirements
Essential
- Ability to travel; locally, nationally and at times internationally
- You may also need to travel between Trust premises as required for the performance of your duties. You may also be expected to work at any of the trust sites. The Trust would consider making reasonable adjustments to the role, if necessary, to enable a disabled person to undertake the 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.
Certificate of Sponsorship
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).
Employer details
Employer name
Northumbria Healthcare NHS Foundation Trust
Address
Manufacturing and Innovation Hub
Avenue Road
Seaton Delaval
NE25 0QJ
United Kingdom
Employer's website
https://www.northumbria.nhs.uk/ (Opens in a new tab)