Band 8a Aseptic / Clinical Trials Pharmacist

We are seeking an experienced Band 8a Aseptic / Clinical Trials Pharmacist to take a key leadership role.
You must be a registered pharmacist with the GPhC to be eligible for this position.
The role is open to full time / part time applicants.
You will:
+ Deputise for the Accountable Pharmacist for Section 10 activities, ensuring MHRA & GMP compliance & for the Head of Production for MS licensed activities.
+ Release aseptic products, safeguarding quality and patient safety.
Support clinical trials under Section 37.
+ Engage in MS licensed production, broadening regulatory expertise.
Collaborate with a multidisciplinary team to deliver services.
We're Looking For, + To deputise for the Head of Production / Aseptic Services ensuring safe and compliant Pharmacy Technical Services are maintained, evaluating and prioritising services when constraints occur, and liaising and negotiating with internal and external stakeholders to
maximise production.
+ To lead a team developing new products and processes using Quality Risk Management (QRM) and Quality by Design (QBD) principles to grow existing services and to widen the scope in line with emerging therapies such as Advanced Therapy Medicinal Products.
+ To create, monitor and review the Capacity and Contingency Plans for Aseptic / Production and Clinical Trial Services
+ To regularly undertake research, creating evidence to support service development and enable the evaluation of services across the manufacturing unit.
+ To work closely with the wider pharmacy clinical trials team, demonstrating senior leadership for this area especially where there is collaboration required between the teams.
+ To participate in product approval of Section 10 products and the release of Manufacturing Specials products., You will be able to find a full Job description and Person Specification attached within the supporting documents or please click "Apply now" to view in Trac.
Why SMPU?
+ Be part of a specialist NHS unit with a reputation for excellence.
+ Work on ground breaking clinical trials shaping future care.
+ Gain exposure to licensed production & expand regulatory knowledge.
+ Enjoy professional development, flexible working & NHS benefits.
Apply now & help deliver life-changing therapies while supporting vital research.
+ To plan, implement, maintain and evaluate clinical production activities including staff, resources, activity, processes, and information, ensuring the highest level of professional standards of service are provided, encompassing both quality and timeliness of service to patients.
+ To manage the overall workload in accordance with the capacity plan ensuring staff rotas reflect an appropriate skill mix for the allocated tasks and are an effective use of staff time, prioritising and adjusting plans as required.
+ To be responsible for ensuring all equipment is validated and functioning correctly, and all plant and equipment planned preventative and corrective maintenance is carried out.
+ To manage the environmental monitoring processes in line with current guidance and to ensure correct action is taken in the event of a deviation. This will include liaising with the Quality Assurance team where appropriate to resolve any validation or monitoring issues.
+ To develop distribution systems and processes under controlled conditions.
+ To ensure that all staff adhere to hygiene and clothing policies associated with their work within the controlled cleanroom environment. This involves strict hand washing procedures and
changing into designated cleanroom clothing.
+ To ensure the digital systems are fit for purpose and approve accuracy of master process and procedure documentation.
+ To contribute to the update and maintenance of the Site Master File in collaboration with the Production Manager and Quality Assurance Lead, analysing data from several sources and
presenting findings for internal use and publication, when required.
+ To be responsible for the handling of 'Controlled drugs' in accordance with professional, ethical and legal guidelines.
MANAGING YOUR APPLICATION

+ A qualified pharmacist with experience in aseptic services, clinical trials or licensed manufacturing.
+ Strong knowledge of GMP, MHRA requirements & quality systems.
+ Excellent leadership, communication and problem-solving skills.
+ A proactive, detail-oriented approach with a drive to advance pharmacy practice.

Cardiff and Vale University Health Board is one of the largest Integrated Health Board in the UK, employing over 16,000 staff and providing over 100 specialist services. Serving a population of around 500,000 people living in Cardiff and the Vale of Glamorgan, we are focussed on the health and care needs of our local population whilst also working with our partners to develop regional services. Together we are committed to improving health outcomes for everyone and to delivering excellent care and support.
Our mission is "Living Well, Caring Well, Working Together". We have recently refreshed our strategy, Shaping Our Future Wellbeing, which sets out the Health Board's Vision for improving the health and wellbeing of the populations we serve by 2035 through the delivery of our strategic objectives; Putting People First, Providing Outstanding Quality, Delivering in the Right Places, and Acting for the Future. We have challenging times ahead, but we are confident that by tackling these challenges together, we can support people to live healthier lives and reduce the unfair differences in the prevalence of illness and health outcomes we see in our communities today. We aspire to deliver outstanding care and treatment for people when they need it, where they need it; care that compares well with the best in the world, but to do so, we need to transform how we deliver services over the next decade and beyond.
We are a values-driven organisation and out goals will only be realised if our values are at the heart of everything we do. Created by colleagues, patients and their families and carers, our values are:
· We are kind and caring
· We are respectful
· We have trust and integrity
· We take personal responsibility
OUR REGION:
Wales has much to offer with miles of stunning coastline, UNESCO world heritage sites and beautiful countryside. Cardiff, the thriving Welsh capital, has something for everyone. It is a fantastic city to live and work in with an abundance of sports, arts and cultural attractions. Situated to the west of Cardiff, the Vale of Glamorgan offers a combination of beautiful Welsh countryside and a dramatic natural coastline, as well as charming towns including Penarth and Cowbridge. Those seeking more culture may find themselves drawn to the National Museum, St Fagan's Museum of Welsh Life or the Millennium Centre, home of the Welsh National Opera. Whether city life or rural living, Cardiff and the Vale offers the best of both worlds.
The Agenda for Change Pay Award for 2026/27 is effective from 1^st April 2026.
Please note successful applicants with a start date from 1^st April onwards the salary will be as per the 2026/27 pay award. For further detail the pay circular is available via this link https://www.nhs.wales/files/pc-resources/afc-w-02-2026-pdf-pdf?ts=1773244958086, Ready to take your pharmacy career to the next level? Join our expert team at St Mary's Pharmaceutical Unit (SMPU) a leading NHS manufacturing facility delivering specialist medicines across Wales & beyond. This is your chance to work at the forefront of aseptic services, clinical trials and licensed production, making a real impact on patient care and research., Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 17,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving over 500,000 people living in Cardiff and the Vale, we are focussed on the health and care needs of our local population whilst working with our partners to develop regional services. Together we are committed to improving health outcomes for everyone, delivering excellent care and support.