Job Details: Associate Director, Analytical Development
Vacancy Name:
Associate Director, Analytical Development Vacancy No:
VN417 Employment Type:
Permanent Location of role:
Abingdon 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 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. Key Responsibilities: Lead CMC analytical development activities from late stage to market application. Manage the analytical team responsible for biopharmaceutical assay development and validation, and technical transfer of assays to external contract manufacturers (CDMO). Contribute relevant CMC analytical data to late stage regulatory submissions, ensuring their integrity and regulatory compliance. Oversee development of analytical methods to support drug substance and drug product release and stability testing for the Immunocore late stage therapeutic drug portfolio. Manage assay development and validation, and technical transfer of assays to external contract manufacturers that comply with Good Manufacturing Practice (GMP). Write/review CMC analytical sections of regulatory submissions (e.g. BLA, MAA) and responses to any agency questions. Plan and lead high impact studies that reduce the risk of drug development projects. Help define the strategic direction within Analytical Development and CMC department. Represent and lead within Immunocore Program teams, providing CMC strategic support and technical consultancy. Prepare reports and presentations of high quality for project teams, senior management, and collaborators. Ensure the highest quality and integrity of laboratory work, electronic records, study reports, and regulatory submissions. Identify and champion new analytical technology opportunities, and lead innovative assay development projects that enhance the drug development process. Develop and mentor staff to help them succeed and grow. Person Specification: Experience and Knowledge: Essential: Significant experience of all analytical aspects of biopharmaceutical CMC development. Recognised as an expert across a wide range of biopharmaceutical analytical methods. Experience with late stage/commercial biopharmaceutical drug programs, including experience of assay and process validation. Experience with biopharmaceutical late stage regulatory submissions (e.g. BLA, MAA), knowledge of relevant regulatory guidelines. Minimum of 2 years relevant experience with people line-management in biopharmaceutical industry. Experience with managing analytical activities at Contract Manufacturing and Development Organisations (CDMO). 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. Contributed to and influenced the strategic scientific direction within the CMC department and company as a whole. Managed external scientific projects including input into negotiations and quality agreements. Key Behavioural Attributes: Taking responsibility, proactively assuming obligations, demonstrating accountability 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. 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 developing long term plans and goals to achieve outcomes. Education & Qualifications: Essential:
BSc. or MSc. in biochemistry, biotechnology or related discipline. Desirable:
PhD in related discipline.
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Vacancy Name:
Associate Director, Analytical Development Vacancy No:
VN417 Employment Type:
Permanent Location of role:
Abingdon 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 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. Key Responsibilities: Lead CMC analytical development activities from late stage to market application. Manage the analytical team responsible for biopharmaceutical assay development and validation, and technical transfer of assays to external contract manufacturers (CDMO). Contribute relevant CMC analytical data to late stage regulatory submissions, ensuring their integrity and regulatory compliance. Oversee development of analytical methods to support drug substance and drug product release and stability testing for the Immunocore late stage therapeutic drug portfolio. Manage assay development and validation, and technical transfer of assays to external contract manufacturers that comply with Good Manufacturing Practice (GMP). Write/review CMC analytical sections of regulatory submissions (e.g. BLA, MAA) and responses to any agency questions. Plan and lead high impact studies that reduce the risk of drug development projects. Help define the strategic direction within Analytical Development and CMC department. Represent and lead within Immunocore Program teams, providing CMC strategic support and technical consultancy. Prepare reports and presentations of high quality for project teams, senior management, and collaborators. Ensure the highest quality and integrity of laboratory work, electronic records, study reports, and regulatory submissions. Identify and champion new analytical technology opportunities, and lead innovative assay development projects that enhance the drug development process. Develop and mentor staff to help them succeed and grow. Person Specification: Experience and Knowledge: Essential: Significant experience of all analytical aspects of biopharmaceutical CMC development. Recognised as an expert across a wide range of biopharmaceutical analytical methods. Experience with late stage/commercial biopharmaceutical drug programs, including experience of assay and process validation. Experience with biopharmaceutical late stage regulatory submissions (e.g. BLA, MAA), knowledge of relevant regulatory guidelines. Minimum of 2 years relevant experience with people line-management in biopharmaceutical industry. Experience with managing analytical activities at Contract Manufacturing and Development Organisations (CDMO). 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. Contributed to and influenced the strategic scientific direction within the CMC department and company as a whole. Managed external scientific projects including input into negotiations and quality agreements. Key Behavioural Attributes: Taking responsibility, proactively assuming obligations, demonstrating accountability 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. 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 developing long term plans and goals to achieve outcomes. Education & Qualifications: Essential:
BSc. or MSc. in biochemistry, biotechnology or related discipline. Desirable:
PhD in related discipline.
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