Principal Scientist I Analytical Development & Validation

As Principal Scientist, Analytical Development, you will set and influence analytical strategies across Immunocore's 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 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.Provide ICH compliant assay validation expertise to the department.Oversee development and qualification of biophysical analytical methods including electrophoretic and chromatographic techniques (e.g., CE-SDS, SE-HPLC, IEX-HPLC, icIEF, excipient quantitation, titre assessment) to support drug substance and drug product release and stability testing.Manage technical transfer and validation of assays at GMP contract manufacturers, develop phase-appropriate specifications, and oversee method performance at Immunocore and CDMOs to identify issues and lead improvements.Support digital transformation initiatives by defining key analytical outputs and streamlining data handling methods.Write and review CMC analytical sections of regulatory submissions (e.g., IMPD, IND, BLA, MAA) and respond to agency questions.Prepare reports and presentations suitable for internal and external audiences.Develop and mentor staff to foster their growth and success.Stay updated on advancements in analytical techniques, providing in-depth analysis and championing new approaches within the company.Review project priorities and provide clear recommendations aligned with overall project, department, and company goals.Implement safe laboratory practices in accordance with Immunocore EHS policies.Qualifications & Experience:Significant experience in biopharmaceutical CMC development, recognized expertise in biophysical analytical methods.Experience with late-stage/ commercial biopharmaceutical drug programs, including assay and process validation.Experience with regulatory submissions (IMPD, IND, BLA, MAA) and knowledge of relevant guidelines.Experience managing analytical activities at CDMOs.Strong project management skills and effective stakeholder communication.Proven ability to present scientific findings and mentor colleagues.Desirable Skills:External scientific network development.Bioinformatics and data management experience in a CMC setting.Contributions to strategic scientific direction.Education & Qualifications:Essential: BSc or MSc in biochemistry, biotechnology, or related discipline.Desirable: PhD in related discipline.Immunocore is committed to creating an inclusive environment and values diversity. We are dedicated to developing innovative therapies that make a difference in patients' lives. #J-18808-Ljbffr

Created: 2025-08-26