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- Tasks: Lead analytical strategies and develop advanced biophysical methods for drug testing.
- Company: Join Immunocore, a pioneering biotech firm transforming medicine with innovative therapies.
- Benefits: Enjoy a collaborative environment, professional growth opportunities, and a commitment to diversity.
- Why this job: Be part of a mission-driven team making a real impact in healthcare and patient lives.
- Qualifications: Significant experience in biopharmaceutical CMC development and a relevant degree required.
- Other info: Opportunity to mentor others and influence strategic scientific direction.
The predicted salary is between 36000 - 60000 £ per year.
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 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 (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 & knowledge
Essential
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
Principal Scientist I Analytical Development & Validation employer: Immunocore
Contact Detail:
Immunocore Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Scientist I Analytical Development & Validation
✨Tip Number 1
Network with professionals in the biopharmaceutical industry, especially those who have experience in analytical development. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in biophysical analytical methods.
✨Tip Number 2
Familiarise yourself with Immunocore's specific therapeutic areas and their innovative TCR platform. Understanding their unique approach will help you articulate how your skills align with their mission during interviews.
✨Tip Number 3
Prepare to discuss your experience with regulatory submissions and assay validation in detail. Be ready to provide examples of how you've successfully navigated these processes in previous roles, as this is crucial for the Principal Scientist position.
✨Tip Number 4
Showcase your leadership and mentoring abilities by preparing anecdotes that highlight your experience in guiding less experienced colleagues. This will demonstrate your capability to develop talent within the team, which is a key responsibility of the role.
We think you need these skills to ace Principal Scientist I Analytical Development & Validation
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in biopharmaceutical CMC development, particularly in analytical methods like electrophoretic and chromatographic techniques. Use specific examples that demonstrate your expertise and achievements in these areas.
Craft a Compelling Cover Letter: In your cover letter, express your passion for developing transformative medicines and how your background aligns with Immunocore's mission. Mention your experience with regulatory submissions and your ability to work within cross-functional teams.
Highlight Leadership and Mentoring Skills: Since the role involves developing and mentoring staff, be sure to include examples of how you've successfully guided less experienced colleagues in scientific practices. This will showcase your leadership abilities and commitment to team success.
Showcase Communication Skills: Demonstrate your ability to communicate complex scientific findings clearly. Include instances where you've presented to both internal and external audiences, as this is crucial for the role at Immunocore.
How to prepare for a job interview at Immunocore
✨Showcase Your Expertise
As a Principal Scientist, it's crucial to demonstrate your deep understanding of biopharmaceutical CMC development. Be prepared to discuss specific analytical methods you've worked with, such as electrophoretic and chromatographic techniques, and how they relate to the role.
✨Prepare for Technical Questions
Expect to face technical questions regarding assay validation and regulatory submissions. Brush up on ICH guidelines and be ready to explain your experience with IMPD, IND, BLA, and MAA submissions, as well as any challenges you've overcome in these areas.
✨Emphasise Collaboration Skills
Immunocore values teamwork and cross-functional collaboration. Highlight your experience working in teams, providing strategic support, and mentoring colleagues. Share examples of how you've successfully engaged with stakeholders at various levels.
✨Demonstrate a Growth Mindset
Show that you are committed to continuous learning and staying updated on industry developments. Discuss any recent advancements in biophysical analytical methods or regulatory changes that could impact the role, and how you plan to integrate this knowledge into your work.
