Specialist, Clinical Supply Chain

About the job

Location of role Gaithersburg, MD, Radnor, PA, Oxford, UK

Department Clinical Supply Chain

The Specialist, Clinical Supply Chain role 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. The Specialist, Clinical Supply Chain 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 either 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 supply

 Contributes 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 studies

 Contributes to the management of labelling, packaging and distribution activities including review and approval of labelling/packaging records and distribution plans

 Helps ensure a seamless provision of drug and ancillary supplies by carrying out activities such as:

o Management of drug temperature excursions during shipment and storage

o Drug usage forecasting

o Contributing to the design and testing of IRT systems during study setup

o Administration and monitoring of IRT systems for drug supply demands

o Arranging and monitoring depot and site shipments as required

o Troubleshooting site clinical pharmacy issues

 Assists with the activities to help monitor individual study budgets including recording in the invoice trackers

 Supports 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 regulations

 When required, contributes to and reviews documents for submissions to regulators or ethics committees

 Assists with the preparation of documentation associated with the assessment, evaluation, and management of CMOs, distribution depots, and other contractors involved with clinical trial supplies

 Provides 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

Essential

 Worked within pharmaceutical quality systems, with a sound understanding of principles of ''good practice''

 Worked within the drug development industry

 Worked collaboratively with other internal teams

 Worked to foster support and influenced all study stakeholders throughout the life of a project

 Worked to meet deadlines

 Worked to an exceptional standard regarding organisational and computer skills (Word, Excel, Powerpoint, Outlook)

Desirable

 Worked in early phase clinical trials

 Knowledge and experience in Oncology therapeutic discipline

 A proven track record of successfully contributing to the running of clinical study projects in a pharmaceutical/biotech business environment

 Worked in GMP or clinical supplies

 Knowledge of the Industry/Clinical trial process and drug development

 Knowledge of ICH GCP

 Knowledge of GDP

 Knowledge of the Clinical Trial Directive and global regulatory environment regarding investigational products

ESSENTIAL COMPETENCIES

1. Communication proficiency in local language

2. Must work with professional discretion and confidentiality

3. High prioritization

4. Self-motivated- able to work autonomously

5. Able to anticipate challenges and devise strategies for success

6. Result and deadline orientated

7. Time management

8. Collaboration skills, and ability to work as part of a diverse team

9. Excellent presentation skills

10. Personal Effectiveness/Credibility

11. Flexibility

12. Technical Capacity

13. Stress Management/Composure

Education & qualifications

 Degree or higher degree in a relevant scientific subject

 Master's or PhD in a relevant scientific subject, desirable

 Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, PowerPoint, Outlook, MS Project, SharePoint)

About 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.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

any other characteristic protected by law.