Head of Research & Development and Innovation
Northumbria Healthcare NHS Foundation Trust
An exceptional opportunity has arisen for a Head of Research & Development and Innovation to play a pivotal role in managing the product development lifecycle, including development and introduction of new products, coordination of stability studies, and formulation development within the Medicines Manufacturing Centre (MMC). The role will also lead on the development of new and innovative methods of manufacture within the MMC such as robotics, fully automated or semi-automated systems as well as working with the MMC senior management team to scope out and deliver further MMC facility and service development opportunities.
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 will ensure a secure supply chain for Systemic Anti-Cancer Therapy (SACT) products for the next 10 years, while also delivering Ready-to-Administer (RtA) medicines to enable nurses to spend more time on patient care.
At MMC, patients and quality are at the heart of everything we do. The success of MMC relies on delivering safe, effective, and innovative medicines for NHS patients. This role is vital in ensuring safe, efficacious products and effective manufacturing processes to maximise delivery of medicines across the North East and North Cumbria region.
Main duties of the job
You will be responsible for delivering new medicinal products and purchasing and introducing new equipment to ensure the MMC is a leading- and cutting-edge pharmaceutical manufacturing facility as well as supporting the Head of Quality and Head of Production in assuring excellence in quality and GMP standards.
Key responsibilities include:
* Provide specialist technical advice and support to ensure development and introduction of GMP compliant systems and equipment at the manufacturing site.
* Lead on the development of new and innovative methods of manufacture within the MMC such as robotics, fully automated or semi-automated systems.
* Manage the product development lifecycle, including development and introduction of new products, coordination of stability studies, and formulation development.
* Manage any process modifications to improve efficiency of established products, and allow longer shelf lives.
* Perform external audits, assessing the standards of suppliers of equipment, starting materials, and services.
* In conjunction with MMC SMT develop and lead on the preparation of robust business cases to support new business opportunities.
About us
The MMC is in its final design stages, with facility construction planned through to September 2025. Initially, staff will be employed by Northumbria Healthcare Foundation NHS Trust, with employment transferring to the Medicines Manufacturing Centre Legal Liability Partnership (LLP) upon its formation under TUPE regulations.
This is a unique opportunity to shape the development and introduction of medicines and specialist manufacturing equipment, ensuring that the MMC delivers the right medicines across the North East and North Cumbria region. If you are passionate about leading new developments in medicines manufacturing, we'd love to hear from you. Apply today and help build the next generation of NHS medicines manufacturing professionals.
Job responsibilities
* To lead on the implementation of a strategy to ensure a robust and fit for purpose workforce within both the MMC NENC PvCv / ICS.
* Manage the product development lifecycle, including development and introduction of new products, coordination of stability studies, and formulation development.
* Manage any process modifications to improve efficiency of established products, and allow longer shelf lives. Publish data in collaboration with national workstreams leading to improvements in patient care nationwide.
* Manage procurement, importation and testing of specialist starting materials, made available to national network of manufacturing sites, using MMC as single point of import.
Person Specification
Qualifications
* Master's degree in a scientific discipline.
* Post graduate qualification in Pharmaceutical Analysis/Quality Assurance.
* Registered Professional with the General Pharmaceutical Council (GPhC), the Health and Care Professions Council (HCPC), Royal Society for Chemistry (RSC), Royal Society for Biology (RSB), or Royal Pharmaceutical Society (RPS).
* Significant post qualification experience in Pharmaceutical Manufacturing, Pharmaceutical Quality Control or Quality Assurance.
* Experience of strategic project management.
* Advanced theoretical and practical knowledge, gained through training, of technical areas of pharmacy, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing and unlicensed medicines.
* Highly specialist QA 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.
* Full Qualified Person eligibility (permanent provisions).
Experience
* Advanced theoretical and practical knowledge, gained through training, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing and unlicensed medicines.
* Previous experience as Head of Production or Head of Quality roles on an MHRA license (MMC contingency).
* Evidence of continuing education/professional CPD.
* Awareness of policies and procedures which impinge on role.
* Detailed knowledge of the manufacture of parenteral nutrition, cytotoxic chemotherapy, intravenous additives, Homecare.
* Microbiology/formulation/product design, and the chemical, pharmaceutical and clinical properties of ingredients.
* Knowledge of gassing isolators.
* Evidence of awareness of the NHSE Aseptic Transformation process.
* Evidence of participating within an MHRA Regulatory inspection.
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, Flexible working, Compressed hours
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