Immunocore is a leading T Cell Receptor (TCR) biotechnology company focused on delivering first-in-class biological therapies that have the potential to transform the lives of people with serious diseases.
We’re on a mission to transform the lives of people with some of the world’s most challenging diseases. Using our soluble TCR platform and ImmTAC® molecules, we can deliver life changing medicine that can target and eliminate cancer. This is your opportunity to join us as a Clinical Supply Chain Administrator and be part of the next phase of our journey, working on a ground-breaking oncology drug that can have a real impact on patients.
MAIN PURPOSE OF THE ROLE
To maintain drug manufacturing and clinical supply chain record keeping in either the Trial Master File or sponsor files in accordance with regulatory expectations. Helping ensure the provision of drug and ancillary supplies across the clinical portfolio. You will work closely with internal clinical supply chain managers and clinical operations to assist the delivery of clinical supplies and ensure appropriate filing in line with related regulatory requirements and internal quality processes.
- Continuously and proactively gathering and filing clinical supplies related paperwork in to either the Trial Master File or the Immunocore controlled filing system. Ensuring records are inspection ready and compliant with regulations.
- Managing and maintaining trial supplies e.g.; Pharmacy Kits, and Lab reagents for sites on non-IRT managed studies. Re-ordering supplies for sites as and when requested by site staff or after periodic prospective study stock-take
- Assisting with clinical supply management when required, such as:
- Assisting with drug temperature excursions during shipment and storage
- Drug usage forecasting across the clinical portfolio
- Monitoring of IRT for drug supply demands
- Assist with drug usage forecasting across the clinical portfolio
- Arranging and monitoring depot and site shipments as required
- Troubleshooting site clinical pharmacy issues
- Supporting the head of department and Clinical Supply Manager in preparing, reviewing and formatting support documents for clinical trials, including: pharmacy handling instructions, pharmacy manual, distribution project specifications etc.
- Contribution towards the reviews of SOPs related to Clinical Supplies and Manufacturing required for the Quality Management system. Ensuring these are compliant with regulations
- When required, contributing to, reviewing, and formatting documents for submissions to regulators or ethics committees
- Assist with the preparation and filing of documentation associated with the assessment, evaluation, and management of CMOs, distribution depots, and other contractors involved with clinical trial supplies
EXPERIENCE & KNOWLEDGE
- Worked collaboratively with teams in a biotech environment
- Worked to meet deadlines on time and to scope
- Worked to an exceptional standard regarding organisational and computer skills (Word, Excel, Powerpoint, Outlook)
EDUCATION & QUALIFICATIONS
Essential: An HND or equivalent