Principal Scientist Analytical Development
2 weeks ago
Full details of the job.
Vacancy Name
Vacancy Name Principal Scientist Analytical Development
Vacancy No
Vacancy No VN222
Employment Type
Employment Type Permanent
Location of role
Location of role Abingdon
About the Company
About the Company 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. We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.Key Responsibilities
Key Responsibilities MAIN PURPOSE OF JOB
To lead development of robust analytical methodologies and devise impurity control strategies to support effective development of the Immunocore therapeutic drug portfolio. Direct a team of analytical scientists to provide quality analytical data to support process development and optimisation. Represent the analytical function within cross-functional project teams. KEY RESPONSIBILITIES• To lead development of robust analytical methods to support effective development of the Immunocore therapeutic drug portfolio, including chromatography purity and impurity, 2D Western blotting as well as host cell protein ELISA, DNA and endotoxin assays
• Lead development and oversight of product and process impurity control strategy and characterisation in aid of product development
• Line manage and direct a team of analytical scientists to provide quality analytical data to support process development and optimisation
• Oversee technical transfer and validation of assays at contract manufacturers in line with ICH regulatory guidelines, and develop phase appropriate specifications
• Provide effective critical assay reagent management strategy
• Represent the function within cross-functional project teams, providing analytical strategic support and technical consultancy
• 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)
• 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 PERSON SPECIFICATION EXPERIENCE AND KNOWLEDGE Essential
• Strong knowledge of large molecule analytical science. Expert in analytical method development in support of biopharmaceutical drug candidate development, including chromatography purity and impurity, 2D Western blotting as well as host cell protein ELISA and endotoxin assays
• Experienced in impurity characterisation and control for biologic drug molecules
• Strong track record of directing projects in a team focussed approach
• Experience with managing analytical activities at Contract Manufacturers.
• 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
• 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 KEY BEHAVIOURAL ATTRIBUTES
• Taking responsibility, proactively assuming obligations, demonstrating accountability and and dealing with the consequences of failure or success.
• Quality mindset that values excellence, continued improvement and attention to detail.
• Building collaborative relationships, developing, maintaining and strengthening partnerships with others who can provide information, assistance and support
• Fostering innovation, developing, proposing and supporting new approaches, methods and technologies that improve effectiveness, working cooperatively with others to produce and implement these innovative solutions.
• Excellent written and oral communication, writing and speaking clearly to share thoughts and information concisely and appropriately.
• Strategic thinking, analysing complex situations, anticipating challenges and develop long term plans and goals to achieve outcomes. EDUCATION & QUALIFICATIONS
• Essential: BSc. or MSc. in biochemistry, molecular biology or related discipline
• Desirable: PhD in related discipline #J-18808-Ljbffr
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