Principal Scientist I Analytical Development & Validation

Immunocore Ltd; Oxford; On-site; GBP 60,000 - 85,000; Full time

Job summary

A leading biotechnology company in Oxford seeks a Principal Scientist I for Analytical Development & Validation. The role involves setting analytical strategies, overseeing assay validation, and providing expertise for regulatory submissions. Candidates should have significant experience in biopharmaceutical development and possess strong project management skills.

Qualifications

• Significant experience in biopharmaceutical CMC development.
• Experience with regulatory submissions and assay validation.
• Established external scientific network preferred.

Responsibilities

• Lead development and qualification of analytical methods.
• Prepare regulatory submissions and respond to agency queries.
• Mentor staff and ensure their professional growth.

Skills

Expertise in biophysical analytical methods

Project management

Communication with stakeholders

Mentoring

Education

BSc or MSc in biochemistry, biotechnology, or related field

PhD in related discipline

Job description

Job Details: Principal Scientist I Analytical Development & Validation

Full details of the job.

Vacancy Name: Principal Scientist I Analytical Development & Validation

Vacancy No: VN663

Employment Type: Permanent

Location: Oxford, UK

Department: CMC

Key Responsibilities

As Principal Scientist in 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, delivering high-quality analytical data and regulatory documentation to support the success of Immunocore’s therapeutic pipeline.

• 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.
• Support digital transformation initiatives by defining key analytical outputs and streamlining data handling.
• Write and review CMC analytical sections of regulatory submissions (IMPD, IND, BLA, MAA) and respond to agency questions.
• Prepare reports and presentations for internal and external audiences.
• Represent the analytical function within cross-functional teams, providing strategic support and technical advice.
• Develop and mentor staff to ensure their professional growth.
• Stay updated on advancements in analytical techniques and incorporate them to improve company processes.
• Review project priorities and provide clear recommendations aligned with overall goals.
• Implement safe working practices in laboratories according to Immunocore EHS policies.

Experience & Knowledge

Essential

• Significant experience in biopharmaceutical CMC development, especially analytical aspects.
• Recognition as an expert in biophysical analytical methods.
• Experience with late-stage/ commercial biopharmaceutical drug programs, including assay and process validation.
• Experience with regulatory submissions and knowledge of relevant guidelines.
• Experience managing analytical activities at CDMOs.
• Proven project management skills and ability to communicate effectively with stakeholders.
• Experience presenting scientific findings and mentoring colleagues.

Desirable

• Established external scientific network.
• Bioinformatics and data management experience.
• Contributions to strategic scientific direction in CMC.

Education & Qualifications

• Essential: BSc or MSc in biochemistry, biotechnology, or related field.
• Desirable: PhD in related discipline.

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company focused on developing transformative medicines for oncology, infectious diseases, and autoimmune diseases. We leverage our innovative soluble TCR platform and ImmTAX molecules to create precision therapies that harness the immune system. We value diversity and are committed to an inclusive workplace, fostering collaboration and innovation to improve patient lives.