Principal Scientist I Analytical Development & Validation - Oxford...

Principal Scientist I Analytical Development & Validation - 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 industrys 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.As Principal Scientist, Analytical Development, you will set and influence analytical strategies across Immunocores therapeutic project portfolio. You will provide ICH-compliant assay validation expertise and lead the development and qualification of advanced biophysical analytical methods to support drug substance and product testing. You will act as a strategic partner within cross-functional teams and deliver high-quality analytical data and regulatory documentation that drive the success of Immunocores therapeutic pipeline.KEY RESPONSIBILITIES* Set and influence analytical program strategies across our therapeutic project portfolio * Represent analytical development within cross-functional project teams, providing strategic support and technical consultancy* Provide ICH compliant assay validation expertise to the department* Oversee development and qualification of biophysical analytical methods including electrophoretic and chromatographic (eg. CE-SDS, SE-HPLC, IEX-HPLC, icIEF, excipient quantitation, titre assessment) methods to support drug substance and drug product release and stability testing for the Immunocore therapeutic drug portfolio. * Oversee technical transfer and validation of assays at GMP contract manufacturers and develop phase appropriate specifications, and maintain oversight of method performance within Immunocore and at CDMOs to identify issues and lead method improvements* Support digital transformation program in defining key analytical outputs and identify methods to streamline data handling* Write/review CMC analytical sections of regulatory submissions (eg. IMPD, IND, BLA, MAA) and responses to any agency questions.* Prepare reports and presentations of high quality suitable for internal and external audiences. * Represent the function within cross-functional project teams, providing analytical strategic support and technical consultancy.* Develop and mentor staff, to help them succeed and grow.* Keep abreast of developments in area of expertise to advance company activities where deemed appropriate; providing in- depth analysis of new techniques and theories to advance the way the company works, raising and championing these with leaders and colleagues across the company* Review competing priorities for projects and provide clear and thorough recommendations, considering the overall goals of the project, department and company.* Implement safe working practices in laboratories for the team according to Immunocore EHS policies.Experience & knowledgeEssential* Significant experience of all analytical aspects of biopharmaceutical CMC development. * Recognised as an expert in one or more biophysical analytical areas including electrophoretic and chromatographic methods.* Experience with late stage/commercial biopharmaceutical drug programs, including experience of assay and process validation. * Experience with biopharmaceutical regulatory submissions (e.g. IMPD, IND, BLA, MAA), knowledge of relevant regulatory guidelines * Experience with managing analytical activities at Contract Manufacturing and Development Organisations (CDMO).* Strong track record of directing projects in a team focussed approach.* Ability to communicate clearly and engage with stakeholders of various levels of seniority effectively.* Presented detailed scientific findings to internal and external audiences.* Mentored and coached less experienced colleagues in scientific practices and theory.Desirable * Built a network of external scientific contacts as both a contributor and recipient.* Bioinformatics and data management experience in a CMC setting.* Contributed to and influenced the strategic scientific direction within the CMC department and company on the whole Education & qualifications* Essential: BSc. Or MSc. in biochemistry, biotechnology or related discipline* Desirable: PhD in related discipline