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.
As Principal Scientist, Analytical Development, you will shape and execute analytical strategies across Immunocore's therapeutic project portfolio, driving the development and oversight of robust impurity analytical methods and control strategies. Acting as a strategic partner within cross-functional teams, you'll provide expert technical consultancy and guide the technical transfer and validation of assays at contract manufacturers. Your leadership will be instrumental in delivering high-quality data and impactful contributions to the advancement of Immunocore's 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.
* Lead development of robust impurity analytical methods to support effective development of the Immunocore therapeutic drug portfolio, including host cell protein ELISA, 2D Western blotting, DNA and endotoxin assays as well as HPLC of residual impurities
* Lead development and oversight of product and process impurity control strategy and characterisation in aid of product development
* Oversee technical transfer and validation of assays at contract manufacturers in line with ICH regulatory guidelines, and develop phase appropriate specifications
* Support digital transformation program in defining key analytical outputs and identify methods to streamline data handling
* Develop scientists of lower grades within the analytical development team
* Prepare reports and presentations of high quality suitable for internal and external audiences
* Be a lead author of relevant sections of CMC regulatory documentation, e.g., IND, IMPD, BLA, MAA and responses to any agency questions
* 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 & knowledge
Essential
* Strong knowledge of large molecule analytical science.
* Expert in analytical method development in support of biopharmaceutical drug candidate development, including host cell protein ELISA, 2D Western blotting as well as HPLC of residual impurities and endotoxin assays
* Experienced in process-related impurity characterisation and control for biologic drug molecules
* Experienced in phase-appropriate assay validation
* Strong track record of collaborating on projects with a team
* Excellent communicator that proactively interacts with cross-functional stake holders
* Presented detailed scientific findings to internal and external audiences
* Mentored and coached less experienced colleagues in scientific practices and theory
* Owned, participated and provided input to regulatory submission documentation and discussions
Desirable
* Experience with Charge Aerosol Detector HPLC methods
* Experience with extractable & leachable assessments
* Bioinformatics and data management experience in a CMC setting
* Built a network of external scientific contacts as both a contributor and recipient
* Contributed to and influenced the strategic scientific direction within the CMC department and company on the whole
* Relevant experience with people line-management in biopharmaceutical industry
Education & qualifications
* Essential: BSc. Or MSc. in biochemistry, molecular biology or related discipline
* Desirable: PhD in related discipline
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