Principal Scientist I Analytical Development & Validation - Oxford

ZipRecruiter; Oxford; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in Oxford is seeking a Principal Scientist I in Analytical Development to define analytical strategies and oversee method qualifications. The ideal candidate will have extensive experience in biopharmaceutical CMC development and strong expertise in biophysical analytical methods. This role offers the opportunity to contribute to innovative therapies and collaborate across teams in a dynamic environment. Competitive compensation and a commitment to employee growth are provided.

Qualifications

• Extensive experience in biopharmaceutical CMC development, especially analytical aspects.
• Expertise in biophysical analytical methods, including electrophoretic and chromatographic techniques.
• Experience managing analytical activities at CDMOs.

Responsibilities

• Define and influence analytical strategies across therapeutic projects.
• Oversee development and qualification of biophysical analytical methods.
• Prepare and review regulatory submissions and respond to agency queries.

Skills

Experience in biopharmaceutical CMC development

Biophysical analytical methods expertise

Project leadership skills

Ability to communicate complex scientific information

Mentoring experience

Education

BSc or MSc in biochemistry, biotechnology, or related field

PhD in a related discipline

Job description

Job Description

Principal Scientist I - Analytical Development & Validation

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. Our R&D leaders are recognized globally for their success in drug development. We foster an innovative environment where great minds collaborate to address significant medical challenges.

We have developed a highly innovative soluble TCR platform and ImmTAX molecules, which are precision-engineered drugs harnessing the immune system to treat diseases with high unmet medical needs. We value our employees as our greatest asset and promote a culture of Science, Trust, Respect, Integrity, and Entrepreneurship (STRIDE), creating a collaborative and innovative workplace.

Immunocore is committed to developing breakthrough therapies that improve patients' lives and advancing medicine. We are an equal opportunity employer, dedicated to fostering an inclusive environment where everyone feels valued and respected. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, gender, expression, origin, or other protected characteristics.

Role Overview: As Principal Scientist in Analytical Development, you will define and influence analytical strategies across our therapeutic portfolio. You will provide ICH-compliant assay validation expertise and lead the development and qualification of advanced biophysical analytical methods supporting drug substance and product testing. You will collaborate cross-functionally to deliver high-quality analytical data and regulatory documentation, contributing to the success of our pipeline.

Key Responsibilities:

1. Set and influence analytical program strategies across our therapeutic projects.
2. Represent analytical development within cross-functional teams, providing strategic support and technical consultancy.
3. Provide ICH-compliant assay validation expertise.
4. Oversee development and qualification of biophysical analytical methods (e.g., CE-SDS, SE-HPLC, IEX-HPLC, icIEF, excipient quantitation, titre assessment) for drug release and stability testing.
5. Manage technical transfer and validation of assays at GMP contract manufacturers, develop phase-appropriate specifications, and oversee method performance to identify issues and implement improvements.
6. Support digital transformation efforts by defining analytical outputs and streamlining data handling.
7. Prepare and review regulatory submissions (IMPD, IND, BLA, MAA) and respond to agency queries.
8. Develop reports and presentations for internal and external audiences.
9. Mentor and develop staff to foster growth and success.
10. Stay abreast of advancements in analytical techniques and incorporate innovative solutions.
11. Review project priorities, providing clear recommendations aligned with overall goals.
12. Implement and promote safe working practices according to company policies.

Experience & Knowledge (Essential):

• Extensive experience in biopharmaceutical CMC development, especially analytical aspects.
• Expertise in biophysical analytical methods, including electrophoretic and chromatographic techniques.
• Experience with late-stage and commercial biopharmaceutical drug programs, including assay and process validation.
• Knowledge of regulatory submissions (IMPD, IND, BLA, MAA) and relevant guidelines.
• Experience managing analytical activities at CDMOs.
• Proven project leadership and stakeholder engagement skills.
• Ability to communicate complex scientific information effectively.
• Mentoring experience for junior colleagues.

Desirable:

• External scientific network development.
• Bioinformatics and data management skills in a CMC context.
• Contributions to strategic scientific direction in CMC.

Education & Qualifications:

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