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Senior Specialist, QC Stability

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Senior Specialist, QC Stability

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ImmunocoreGet AI-powered advice on this job and more exclusive features.Location of role

Oxford, UK

Department

CMC

Key Responsibilities

Join forces with a dynamic team to drive our product pipeline forward! Collaborate closely with external QC contract laboratories to design, initiate, and track the performance of stability studies. Together, you''ll ensure the robustness and integrity of all raw data and results, adhering to the highest quality standards.

Integral to your role will be QC trending and study evaluation, working hand-in-hand with colleagues to support regulatory submissions and develop shelf-life proposals for both clinical and commercial supplies. You''ll be a key player in managing and reviewing Quality Events, including OOS, OOT, non-conformances, and change controls, fostering a culture of continuous improvement.

By assessing related Immunocore systems, you''ll uncover opportunities for enhancement, driving collective success. Be part of a team that makes a tangible impact on patient care and product excellence through collaboration and shared expertise!

Key Responsibilities

Primary point of contact for external QC contract laboratory stability operations, with responsibility for continuous oversight of performance.

Collaborate on stability study designs and scope, to meet Immunocore project requirements.

Provide input and review stability protocols and quotes with QC contract laboratories, with approvals compliant with Immunocore procedures.

Liaise with QC contract laboratories to ensure stability scheduling delivers to meet Immunocore project timelines, both in compliance with protocol and Quality Technical Agreements.

Manage tracking of all outsourced QC contract laboratory stability studies, communicating status or delays across project teams

Receive appropriately stability testing raw data and reports, ensuring documented QC review process, and filing in Product Specification File, as necessary.

Receive stability study quality investigations from contract laboratories for appropriate internal assessment, documented review, and filing in Product Specification File, as necessary.

Responsible for the evaluation of stability results from contract testing laboratories, including real time updates to trending charts, performing relevant statistical analyses, escalating issues to QC Stability Director, and reporting progress to CMC project teams.

Perform Trending of Product stability studies to justify proposed Product shelf-life regulatory submissions

Perform and manage QC checking of all stability output from QC contract laboratories, ensuring robust data integrity for inclusion in regulatory submissions.

Support internal development stability study operations with QC and technical reviews of testing, trending, reporting, and input to quality investigations.

Stability lead role on selected Immunocore projects, communicating updates at CMC meetings.

Performing assessments for temperature excursions to support clinical material.

Prepare statements of stability for shelf-life extensions and changes to batch expiry date, for communication with clinical supply team and external collaborators.

Support author, review, and QC check stability modules of regulatory submissions, as required.

Maintain knowledge and keep up to date with current ICH and other applicable regulatory guidelines.

Ownership, authoring and periodic reviewing of policies and procedures governing outsourced QC/Stability operations, ensuring they remain ‘fit-for-purpose’.

Ensure stability operations are performed in compliance with the Immunocore QMS.

Champion Quality, both for internal and external studies, ensuring all work is completed to a consistently high level of accuracy and compliance, while pro-actively assessing QC systems for continuous improvement opportunities.

Ensure training is received, up to date, and documented / recorded to support this Quality role.

Champion and live the Immunocore Health and Safety Culture.

Essential

EXPERIENCE AND KNOWLEDGE

Proven experience of Quality Control testing to SOPs and working to GMP compliance.Extensive knowledge of stability studies for Biological Products, including study design, testing requirements, quality checking, specifications, quality investigations, data integrity.Good understanding of stability and related ICH / other regulatory guidelines.Experience with analytical methods for Biologics, validation, and method performance controls.Understanding of system suitability criteria and assay acceptance criteria for assessing test validityExperienced in writing study documents, including protocols and reports.Performing stability trending and analysis to support product shelf-lifeExperience with sample management and ensuring cold chain compliance of test articlesWorking to QMS procedures and documenting Quality events (e.g., OOS, NCs)Demonstrated good organizational and communication (verbal and written) skills, proactively contributing to a diverse team environment.

Desirable

Knowledge of bioassays, biopharmaceutical assays, statistical evaluation of assay variabilityUnderstanding of analytical requirements to support biological clinical and commercial products.Knowledge of method validation requirements to demonstrate stability indicating capabilities.Mentored and coached less experienced colleagues in scientific and stability related projects.

Education and Qualifications

Essential: BSc. Or MSc. in protein engineering, biochemistry, molecular biology, or related disciplineDesirable: PhD in related discipline

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 RandD 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.Seniority level

Seniority level Mid-Senior levelEmployment type

Employment type ContractJob function

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