Job Details
Job Details: Clinical Supply Chain Specialist
Full details of the job.Vacancy NameVacancy Name
Clinical Supply Chain SpecialistVacancy NoVacancy No
VN169Employment TypeEmployment Type
Full TimeLocation of roleLocation of role
Abingdon, Rockville, ConshohockenAbout the CompanyAbout the Company
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.Key ResponsibilitiesKey Responsibilities
The Clinical Supplies Specialist will maintain drug manufacturing and clinical supply chain record keeping in either the Trial Master File or sponsor files in accordance with regulatory expectations. Helping to ensure effective management of drug manufacturing and the supply chain, ensuring seamless provision of drug and ancillary supplies across the clinical portfolio. They will work closely with internal clinical supply chains, clinical operations, regulatory and manufacturing colleagues to assist in the delivery of clinical supplies in line with related regulatory requirements and internal quality processes.
KEY RESPONSIBILITIES:
Continuously and proactively gathers and files clinical supplies related paperwork into the Trial Master File or sponsor files. Ensuring records are inspection ready and compliant with regulations.Collaborates with Clinical Supplies Managers in setup of supply chain strategies for clinical studies, resolving issues, sharing best practice, and continually developing competence. Seeks out expert input and support from cross-functional groups as necessary.Together with Clinical Supply Managers, designs and implements labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites, and the relevant regulatory authorities, but also maximizes efficiency of supplyContributes to clinical supply agreement document, documenting the agreed supply option providing details of the design, setup and how the supply chain will operate for responsible studies or group of studiesContributes to the management of labelling, packaging and distribution activities including review and approval of labelling/packaging records and distribution plansHelps ensure a seamless provision of drug and ancillary supplies by carrying out activities such as:o Management of drug temperature excursions during shipment and storageo Drug usage forecastingo Contributing to the design and testing of IRT systems during study setupo Administration and monitoring of IRT systems for drug supply demandso Arranging and monitoring depot and site shipments as requiredo Troubleshooting site clinical pharmacy issuesAssists with the activities to help monitor individual study budgets including recording in the invoice trackersSupports in preparing, reviewing, and formatting support documents for clinical trials, including pharmacy handling instructions, pharmacy manual, distribution project specifications etc.Contributes to and reviews SOPs related to Clinical Supplies and Manufacturing required for the Quality Management system, ensuring these are compliant with regulationsWhen required, contributes to and reviews documents for submissions to regulators or ethics committeesAssists with the preparation of documentation associated with the assessment, evaluation, and management of CMOs, distribution depots, and other contractors involved with clinical trial suppliesProvides pharmacy training to clinical trial personnel as necessary. This may involve travelling nationally and internationally for face-to-face training when required.Initiates Quality Events where appropriate and supports to investigate and perform root cause analysis and execution of associated CAPAs
Experience & knowledge:EssentialWorked within pharmaceutical quality systems, with a sound understanding of principles of ''good practice''Worked within the drug development industryWorked collaboratively with other internal teamsWorked to foster support and influenced all study stakeholders throughout the life of a projectWorked to meet deadlinesWorked to an exceptional standard regarding organizational and computer skills (Word, Excel, PowerPoint, Outlook)
DesirableWorked in early phase clinical trialsKnowledge and experience in Oncology therapeutic disciplineA proven track record of successfully contributing to the running of clinical study projects in a pharmaceutical/biotech business environmentWorked in GMP or clinical suppliesKnowledge of the Industry/Clinical trial process and drug developmentKnowledge of ICH GCPKnowledge of GDPKnowledge of the Clinical Trial Directive and global regulatory environment regarding investigational products
Education & qualifications:
Degree or higher degree in a relevant scientific subjectMaster's or PhD in a relevant scientific subject, desirableDemonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, PowerPoint, Outlook, MS Project, SharePoint)
#J-18808-Ljbffr