Job summary
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
To provide leadership on production related aspects within the MMC.
To meet clinical needs within the Integrated Care Services (ICS) for ready to use sterile injectable medicinal products.
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 process 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 description
Job responsibilities
Implement production policies which complies with Good Manufacturing Practice and current standards documents.
To lead in the creation of user requirement specifications for manufacturing equipment.
To select the contractors to provide the facility ensuring functional specification compliance with the user requirement specifications.
To manage the new product introduction process including process validation.
To assist in the development strategy to ensure a robust and fit for purpose manufacturing workforce.
To manage contractors and to lead on the commissioning and qualification of facilities and manufacturing equipment.
To manage the storage and distribution of manufactured medicines.
To lead on the ongoing maintenance and re-qualification of theMMCfacilities
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 interview.
Job description
Job responsibilities
Implement production policies which complies with Good Manufacturing Practice and current standards documents.
To lead in the creation of user requirement specifications for manufacturing equipment.
To select the contractors to provide the facility ensuring functional specification compliance with the user requirement specifications.
To manage the new product introduction process including process validation.
To assist in the development strategy to ensure a robust and fit for purpose manufacturing workforce.
To manage contractors and to lead on the commissioning and qualification of facilities and manufacturing equipment.
To manage the storage and distribution of manufactured medicines.
To lead on the ongoing maintenance and re-qualification of theMMCfacilities
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 interview.
Person Specification
Skills & Knowledge
Essential
- 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
Desirable
- Postgraduate diploma in Pharmaceutical Technology and Quality Assurance
- Management qualification
Experience and Knowledge
Essential
- Advanced theoretical and practical knowledge, gained through training, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing and unlicensed medicines.
Person Specification
Skills & Knowledge
Essential
- 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
Desirable
- Postgraduate diploma in Pharmaceutical Technology and Quality Assurance
- Management qualification
Experience and Knowledge
Essential
- 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.
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
