Immunocore

Job Details: Senior Scientist I - Analytical Development & Validation Full details of the job. Vacancy Name Vacancy Name Senior Scientist I - Analytical Development & Validation Vacancy No Vacancy No VN627 Employment Type Employment Type Permanent Location of role Location of role Oxford, UK Department Department CMC Key Responsibilities To conduct and design experimental investigations enabling the advancement of the Company pipeline, process, or technology capabilities, proposing improvements for consideration by colleagues and managers. To perform assay development and qualification for ImmTAX and other TCR based molecules and oversee method transfers to CDMOs. Designing and conducting chromatographic, electrophoretic and immunoassay development studies to support stability and release of ImmTAC and other TCR based molecules. Supporting qualification of chromatographic, electrophoretic and immunoassay methods (according to ICH guidelines) to allow release testing of the company drug molecules. Contributing to method transfers to contract development and manufacturing organisations (CDMO). Leading investigational, CMC supportive packages and comparability studies of biologics/drug products. Writing study protocols and reports. Independently testing and, increasingly, leading lines of investigation. Proposing new experiments based on emerging data and other related information. Providing support on technical aspects to others. Priorities: establishing priorities for own work and team-based projects; making decisions on prioritisation based on the overall goals of the team, department and project, using direct evidence and personal experience as guidance. Technical Knowledge: sharing knowledge with the wider team and, across departments representing the department both internally and externally. May also act as a mentor or manager to other colleagues, especially new hires, sharing scientific and company knowledge. Increasingly providing analysis of new techniques and theories from outside the Company to advance the way the company works; sharing these with leaders across the Company. Laboratory records: ensuring that all records and information are up to date, on time and recorded to the correct standard. Supporting and encouraging others to achieve this. Laboratory equipment: providing technical guidance to others within the team on how to use equipment most effectively; making recommendations regarding acquisition of new pieces of equipment. Reporting: communicating and presenting research findings at meetings with colleagues, senior management and partners. Adhere to safe working practices in laboratories according to Immunocore EHS policies. Person Specification Experience & knowledge Essential Experience in development of chromatographic and electrophoretic methods used in the analysis of recombinant proteins or antibodies. Worked in a bench-based biopharmaceutical laboratory environment. Established as an expert amongst peers in one or more of the following areas: electrophoretic, chromatographic, immuno-analytical. Experienced in assay qualification/validation and/ or system suitability i.e. robustness analytical limits. Familiar with biopharmaceutical stability study principles and interpretation thereof. Worked and contributed actively in a diverse team environment. Proposed and driven changes in working practices that have improved efficiency, supported teams through adoption and change. Presented detailed scientific findings and papers to internal and external audiences. Mentored and coached less experienced colleagues in scientific practices and theory. Desirable Experience with late stage/commercial biopharmaceutical assay development and characterisation. Familiar with the principles of Good Manufacturing Practise (GMP). Presented papers at external conferences. Participated in external scientific experiments and/or analytical collaborations. Led a small project team, formally or informally, through a change in practice including project management. Understanding of analytical requirements to support materials for use in clinical trials. Education & qualifications Essential: BSc. Or MSc. in biochemistry, biotechnology or related discipline. Desirable: 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 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.

Full details of the job. Key Responsibilities The Senior Director of Competitive Intelligence will serve as a strategic leader within Immunocore, integrating deep competitive insights with early commercial thinking to shape the company's R&D and portfolio strategy. This role will be pivotal in identifying opportunities, anticipating market dynamics, and informing key decisions across the product lifecycle-from discovery through late stage development. This individual will partner closely with R&D, Commercial, and Business Development teams to ensure Immunocore's pipeline is positioned for long term success in a rapidly evolving immuno oncology landscape. Strategic Competitive Intelligence Leadership: Lead the development and execution of a global CI strategy across Immunocore's pipeline and therapeutic focus areas. Serve as the enterprise wide expert on competitor dynamics, emerging threats, and new opportunities. Deliver real time intelligence and strategic implications from competitor activities, clinical developments, and regulatory milestones. Lead competitive coverage for major scientific and medical congresses, synthesizing key takeaways and implications. Lead the CI/Strategy team to deliver robust competitive analyses that are integrated into program and portfolio strategy. Translate complex data into actionable insights that inform portfolio prioritization and development opportunities. Competitive Intelligence Team Leadership & Capability Building: Build and mentor a high performing CI and early commercial team as the function scales. Continue to evolve best practices, tools, and processes for CI. Foster a culture of strategic thinking, cross functional collaboration, and continuous learning. Early Commercial, Program & Portfolio Strategy: Collaborate with Program Leaders and Program Teams to integrate CI and commercial insights into clinical trial design, indication selection, and investment decisions. Conduct market opportunity assessments, including patient segmentation, treatment algorithms, and unmet needs. Inform potential commercial risks and considerations early in development, including pricing, access, and reimbursement considerations. Drive development of target product profiles (TPPs) to align with future commercial success. Monitor evolving standards of care to anticipate future market challenges and opportunities. Lead business case development for new indications and pipeline investments, incorporating scientific, clinical, and commercial perspectives. Support long range planning and scenario modelling to guide Immunocore's growth strategy. Identify and execute cross portfolio analyses and strategies that deliver value for platform or company strategy. Executive Engagement & Strategic Communication: Deliver high impact presentations and strategic briefings to Executive Leadership, Board of Directors, and key stakeholders. Represent CI and Early Commercial Strategy in governance forums and cross functional strategic initiatives. Business Development & External Innovation: Partner with BD to identify and evaluate external opportunities. Support deep dive assessments of external assets, platforms, and companies to support due diligence and strategic fit analyses. Track landscape for competitor partnering strategies. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Supervisory Responsibility (If applicable): Role will lead, manage and mentor the CI/Early commercial strategy team. Education, Experience and Knowledge Bachelor's degree in life sciences or related field with 20+ years of related experience or equivalent experience required. Advanced degree (PhD, MBA, MD) strongly preferred. 10+ years of experience in competitive intelligence, commercial strategy, or business development within the biotech/pharma industry. Strong background in oncology highly preferred. Proven track record of influencing portfolio and program decisions through strategic insights and commercial acumen. Excellent communication and presentation skills - ability to present clear analysis to senior leadership and the board of directors. Deep understanding of drug development, clinical trial design, and commercialization pathways. Experience in a global, matrixed organization with cross functional leadership responsibilities. Excellent analytical abilities. Extensive experience in biotech / pharma via industry, banking or strategy consultancy roles. Understanding of scientific, clinical and market data to identify patterns and opportunities. Deep understanding of the drug development process. Expert knowledge of a wide range of competitor information sources. Experience performing complex competitor and market opportunity analysis. Experience in a global matrix environment across a range of functions, seniority, and locations. Demonstrated ability to collate and structure data from multiple sources to form a clear narrative and distil key issues. Demonstrated ability to independently undertake competitive analysis projects. Demonstrated ability to influence without authority and establish and maintain credibility with senior audiences. Excellent strategic thinking. Highly analytical with strong business and scientific acumen. Exceptional communication and presentation skills. Ability to influence in a global matrix environment. Proactive, resourceful, and results oriented. Comfortable navigating ambiguity and complexity. IMMUNOCORE Values 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. Equal Opportunity Statement 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. 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.

Job Details: Executive Director, Head of Quality Assurance Full details of the job. Vacancy Name Vacancy Name Executive Director, Head of Quality Assurance Vacancy No Vacancy No VN675 Employment Type Employment Type Full Time Location of role Location of role Conshohocken, PA Gaithersburg, MD Oxford, UK Department Department Clinical QA Key Responsibilities Key Responsibilities The Head of Quality Assurance (QA) is a senior leadership role responsible for the strategic direction, oversight, and continuous improvement of the Quality Assurance function across a dynamic, research-driven, and commercial biopharmaceutical organization. This individual will provide enterprise-wide leadership, ensuring robust quality systems and compliance with all applicable GxP (Good Practice) regulations across manufacturing, research, and development. The Head of QA will drive new quality initiatives, work cross-functionally to align on priorities, and ensure the organization meets the highest standards of product quality, patient safety, and regulatory compliance. • To oversee, manage and lead the Quality Assurance Department and take the lead to ensure Immunocore is fully compliant with all appropriate regulatory authorities • To lead and promote joined up quality thinking and decision making across all internal and external operations. • To build a high performing, motivated and skilled Quality team capable of delivering to the standards required • To lead by example, inspire the Quality team to outperform • To take full accountability for the Quality and Compliance activities for the UK and US teams • To take lead to ensure Immunocore is fully compliant as a marketing authorization holder, meeting regulatory and quality standards whilst maintaining compliance to GXP and license commitments. • To take lead on and full accountability for Immunocore's Quality Assurance Management System. • To assume the Site Subject Matter Expert role, liaising directly with internal and external customers on all subjects related to Quality • To oversee the Regulatory Authority and Audit Inspections and ensure company is prepared for these inspections. Key Responsibilities: • Provide enterprise leadership for the Quality Assurance function, setting the vision and strategy to support both research and commercial operations. • Identify, propose, and lead new quality initiatives that drive continuous improvement and operational excellence across the organization. • Collaborate cross-functionally with Manufacturing, Research & Development, Regulatory Affairs, Supply Chain, and other key stakeholders to align on initiative scope, timing, resource needs, and prioritization. • Lead and harmonize quality systems and processes across all GxP areas (GMP, GLP, GCP), ensuring compliance with global regulatory requirements and industry best practices. • Serve as the primary quality representative in executive leadership forums, providing guidance on risk management, compliance, and quality culture. • Oversee the development, implementation, and maintenance of quality policies, procedures, and training programs. • Ensure effective management of internal and external audits, regulatory inspections, and timely resolution of findings. • Monitor and report on key quality metrics, trends, and risks to senior leadership, driving accountability and transparency. • Foster a culture of quality, integrity, and continuous improvement throughout the organization. • Mentor and develop a high-performing QA team, building organizational capability and succession planning. • To promote and embed a culture of Quality Assurance excellence and readiness for inspection throughout Immunocore and its partner organizations. • To conduct external audits of existing contract manufacturers and suppliers and conduct vendor assessment/selection for all new manufacturers, suppliers and providers. • To develop and maintain and champion electronic QMS system to track and store all of the key elements related to QA (training, QE, NC, CAPA, RCA, etc • To liaise with the QA team and oversee all aspects of Change Control and deviations from specification and the validation required before changes can be implemented. • To provide documented feedback relating to all audits and ensure standards are applied and met with follow up training programs and improvements to QA best practice and process within Immunocore. • To promote a culture where people are focused on quality, compliance, and inspection readiness by design from the start of any company process and to keep the senior leadership informed of any problems relating to QA issues. • Support and develop Company Training sessions regarding Quality and Compliance in order to promote a culture of quality and compliance. Supervisory Responsibility: This position will be responsible for supervisory responsibilities. Education, Experience and Knowledge: Advanced degree in life sciences, pharmacy, engineering, or a related field; PhD, MS, or equivalent preferred. BS/BA in life sciences, pharmacy, or related field with appropriate experience and track record. 10+ years of progressive experience in Quality Assurance within the biopharmaceutical industry, with significant leadership experience across both research and commercial environments. Deep knowledge of global GxP regulations (GMP, GLP, GCP) and experience leading quality systems in both manufacturing and R&D settings. Demonstrated success in leading cross-functional teams and driving enterprise-wide initiatives. Strong strategic thinking, problem-solving, and decision-making skills. Excellent communication (written and verbal), negotiation, and interpersonal skills, with the ability to influence at all levels of the organization. Proven ability to manage multiple priorities in a fast-paced, evolving environment. Specific experience and expectations: Able to develop and lead a QA team responsible for ensuring GXP compliance across all functional areas. Successfully conducted inspections by FDA, MHRA and other Health Authorities (HAs). Successfully led organization to resolve findings from inspections by a recognized Heath Authority. Demonstrated abilities to train others on root cause analysis, QE identification and CAPA resolutions. Demonstrated ability to identify critical findings from major and minor observations. A strong team player with the ability to respond to others in a supportive and flexible manner, and a willingness and ability to contribute as an individual subject matter expert conducting audits and other activities. Possess a sense of urgency and to be able to instill that urgency in the team. Analytical Thinking - Tackling problems using a logical, systematic and sequential approach, identifying discrepancies and inconsistencies. Managing Self Performance - Taking responsibility for own performance, clarifying expectations and promptly notifying managers/colleagues of problems affecting potential completion of goals. About the Company 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.