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- Tasks: Lead QC stability studies and ensure data integrity for transformative medicines.
- Company: Join Immunocore, a pioneering biotech firm revolutionising patient care with innovative therapies.
- Benefits: Enjoy a collaborative environment, career growth opportunities, and a commitment to diversity and inclusion.
- Why this job: Make a real impact on patient lives while working with industry leaders in a dynamic setting.
- Qualifications: BSc or MSc in relevant fields; experience in Quality Control and stability studies is essential.
- Other info: Embrace a culture of continuous improvement and champion quality in all operations.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Senior Specialist, QC Stability – OxfordImmunocore (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.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 & scope, to meet Immunocore project requirements.Provide input & review stability protocols & 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 teamsReceive 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, & 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 submissionsPerform & 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 & 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 & keep up to date with current ICH and other applicable regulatory guidelines.Ownership, authoring and periodic reviewing of policies & 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 & 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 & Safety Culture.EXPERIENCE AND KNOWLEDGEEssential* 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, & method performance controls.* Understanding of system suitability criteria and assay acceptance criteria for assessing test validity * Experienced in writing study documents, including protocols & reports.* Performing stability trending and analysis to support product shelf-life* Experience with sample management and ensuring cold chain compliance of test articles* Working 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 variability * Understanding 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 & QUALIFICATIONS* Essential: BSc. Or MSc. in protein engineering, biochemistry, molecular biology, or related discipline* Desirable: PhD in related discipline
Senior Specialist, QC Stability - Oxford employer: Immunocore
Contact Detail:
Immunocore Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist, QC Stability - Oxford
✨Tip Number 1
Familiarise yourself with Immunocore's innovative TCR platform and their approach to developing biological therapies. Understanding their mission and values will help you align your experience and passion with what they are looking for in a candidate.
✨Tip Number 2
Network with current or former employees of Immunocore, especially those in QC or stability roles. They can provide valuable insights into the company culture and expectations, which can be beneficial during interviews.
✨Tip Number 3
Stay updated on the latest ICH guidelines and regulatory requirements related to stability studies. Demonstrating your knowledge of these regulations during discussions can set you apart as a well-informed candidate.
✨Tip Number 4
Prepare to discuss specific examples from your past experience that showcase your ability to manage QC processes and improve data integrity. Highlighting your problem-solving skills in real-world scenarios will resonate well with the hiring team.
We think you need these skills to ace Senior Specialist, QC Stability - Oxford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Control testing and stability studies. Use specific examples that demonstrate your knowledge of GMP compliance and your ability to work with biological products.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Mention how your values align with Immunocore's STRIDE principles and provide examples of how you've contributed to team success in previous roles.
Highlight Relevant Skills: Emphasise your skills in analytical methods, data integrity, and quality investigations. Be specific about your experience with stability trending and analysis, as these are crucial for the position.
Showcase Continuous Improvement Mindset: Demonstrate your commitment to continuous improvement by providing examples of how you've identified and implemented enhancements in previous roles. This aligns well with Immunocore's focus on fostering a culture of quality and innovation.
How to prepare for a job interview at Immunocore
✨Showcase Your Technical Expertise
Make sure to highlight your experience with Quality Control testing and stability studies during the interview. Be prepared to discuss specific examples of how you've designed stability studies or managed QC processes, as this role requires a deep understanding of these areas.
✨Demonstrate Your Knowledge of Regulatory Guidelines
Familiarise yourself with ICH and other relevant regulatory guidelines before the interview. Being able to discuss how these guidelines impact stability studies and quality control will show that you are well-prepared and knowledgeable about industry standards.
✨Emphasise Collaboration Skills
Since the role involves working closely with external QC contract laboratories and internal teams, be ready to share examples of how you've successfully collaborated in previous roles. Highlight your communication skills and ability to work in diverse teams.
✨Prepare for Problem-Solving Questions
Expect questions that assess your problem-solving abilities, especially regarding quality events like OOS or non-conformances. Think of scenarios where you've had to troubleshoot issues and how you approached them, as this will demonstrate your critical thinking skills.
