Northumbria Healthcare NHS Foundation Trust
An exceptional opportunity has arisen to provide Production leadership within the purpose-built Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC will produce sterile injectable medicinal products in line with MHRA Good Manufacturing Practice on behalf of the North East and North Cumbria Provider Collaborative. The post holder will act as deputy for the Head of Production and be responsible for the creation of production processes, training materials, SOPs, and other quality documents.
Main Duties of the Job
1. To provide leadership on production-related aspects within the MMC.
2. To meet clinical needs within the Integrated Care Services (ICS) for ready-to-use sterile injectable medicinal products.
3. To support the establishment of the MMC as a leading Manufacturing Centre within the national NHS framework for aseptic transformation.
About Us
The MMC is in the late stages of design, with the facility build phase planned through to September 2025. This presents an exciting opportunity to be involved in the design and build of a new facility, the development of new production processes, and contribution to establishing a functional PQS for the facility.
A successful candidate will be integral in establishing the production team for the delivery of anti-cancer and ready-to-administer sterile medicines for use in all 8 acute NHS Trusts in the NENC region.
Staff will be employed by Northumbria Healthcare Foundation NHS Trust until the formation of the Medicines Manufacturing Centre Legal Liability Partnership (LLP) is formed as a legal entity, after which TUPE regulations will apply.
Job Responsibilities
1. Implement production policies that comply with Good Manufacturing Practice and current standards documents.
2. Lead in the creation of user requirement specifications for manufacturing equipment.
3. Select the contractors to provide the facility ensuring functional specification compliance with the user requirement specifications.
4. Manage the new product introduction process including process validation.
5. Assist in the development strategy to ensure a robust and fit-for-purpose manufacturing workforce.
6. Manage contractors and lead on the commissioning and qualification of facilities and manufacturing equipment.
7. Manage the storage and distribution of manufactured medicines.
8. Lead on the ongoing maintenance and re-qualification of the MMC facilities.
Interview Information
Candidates will be presented with a scenario before the interview and allowed time to review and make notes, which will be presented and discussed with the panel during the interview.
Person Specification
Skills & Knowledge
* Master's degree in a scientific discipline or equivalent experience.
* Registered Professional with the General Pharmaceutical Council (GPhC) or Academy for Healthcare Science (AHCS).
* Post-graduate qualification in Pharmaceutical Manufacturing or equivalent experience.
* Postgraduate diploma in Pharmaceutical Technology and Quality Assurance.
Experience and Knowledge
* Advanced theoretical and practical knowledge, gained through training, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing, and unlicensed medicines.
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.
Northumbria Healthcare NHS Foundation Trust
Full-time, Part-time, Job share, Flexible working, Compressed hours
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