Associate Director, Analytical Development

1 month ago

Abingdon Oxfordshire, United Kingdom Immunocore Full time
Job Details: Associate Director, Analytical Development

Full details of the job.

Vacancy Name

Vacancy Name Associate Director, Analytical Development

Vacancy No

Vacancy No VN417

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 The main purpose of the role is to lead CMC analytical development activities from late stage to market application. Management of the analytical team responsible for biopharmaceutical assay development and validation, and technical transfer of assays to external contract manufacturers (CDMO). Responsible for contribution of relevant CMC analytical data to late stage regulatory submissions, ensuring their integrity and regulatory compliance.
KEY RESPONSIBILITIES

• Responsible for drug substance and drug product CMC analytical development activities from late stage to product licensure.
• Managing an analytical team of graduate scientists, who conduct analytical studies in support of manufacturing operations and regulatory submissions.
• 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 (eg. 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.
• Representation and leadership 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 on the 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, 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, biotechnology or related discipline
• Desirable: PhD in related discipline #J-18808-Ljbffr

  • Pensions Associate/Senior Associate/Director

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Associate Director, Regulatory Affairs CMC Vacancy Name Associate Director, Regulatory Affairs CMC Employment Type Permanent 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...

  • Associate Director, Regulatory Affairs CMC

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Job Details: Associate Director, Regulatory Affairs CMC Full details of the job. Vacancy Name Vacancy Name Associate Director, Regulatory Affairs CMC Vacancy No Vacancy No VN194 Employment Type Employment Type Permanent Location of role Location of role Abingdon About the Company About the Company Immunocore (NASDAQ: IMCR) is a pioneering,...

  • Principal Scientist Analytical Development

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Job Details: Principal Scientist Analytical Development 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,...

  • Associate Director, Marketing

    1 month ago

    Oxfordshire, United Kingdom Redline Group Ltd Full time

    My client based in Oxford design and manufacture a range of complex, high value electronic products that are used all over the world. They are currently seeking an Associate Director - Marketing to join their growing team in Oxford The Associate Director - Marketing job will lead in the continued development of the digital engagement strategy and editorial...

  • Associate Director

    3 weeks ago

    Abingdon, Oxfordshire, United Kingdom RPS Group Full time

    We are working on some of the most exciting Nationally Significant Infrastructure Projects in the UK and internationally, including large scale energy projects – think GW rather than MW! This includes solar, offshore wind, international interconnector and energy storage projects. We are the EIA lead for the Gatwick Airport Northern Runway Project, Morgan...

  • Associate Director, Regulatory Operations-hybrid

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...

  • Senior Analytical Development Scientist

    4 weeks ago

    Oxfordshire, United Kingdom Northreach Full time

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional...

  • Senior Analytical Development Scientist

    4 days ago

    Oxfordshire, United Kingdom Northreach Full time

    Job Description Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and...

  • Senior Analytical Development Scientist

    4 weeks ago

    Oxfordshire, United Kingdom Northreach Full time

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional...

  • Senior Analytical Development Scientist

    2 weeks ago

    Oxfordshire, United Kingdom Northreach Full time

    Job DescriptionNorthreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and...

  • Senior Analytical Development Scientist

    4 weeks ago

    Oxfordshire, United Kingdom Northreach Full time

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional...

  • Senior Analytical Development Scientist

    4 weeks ago

    Oxfordshire, United Kingdom Northreach Full time

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional...

  • Senior Analytical Development Scientist

    4 weeks ago

    Oxfordshire, United Kingdom Northreach Full time

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional...

  • Senior Analytical Development Scientist

    3 weeks ago

    Oxfordshire, United Kingdom Northreach Full time

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth....

  • Director, Clinical Scientist

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...

  • Director, Physician for Infectious Disease

    14 hours ago

    Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Job Details: Director, Physician for Infectious Disease - Clinical Development Full details of the job. Vacancy Name Vacancy Name Director, Physician for Infectious Disease - Clinical Development Vacancy No Vacancy No VN353 Employment Type Employment Type Permanent Location of role Location of role Abingdon About the Company About the Company...

  • Associate Director, Regulatory Operations

    1 month ago

    Abingdon, United Kingdom Adaptimmune Full time

    **Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K. and U.S.based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...

  • Senior Analytical Development Scientist

    4 days ago

    Oxford, Oxfordshire, United Kingdom Northreach Full time

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional...

  • Senior Scientist

    1 month ago

    Abingdon, United Kingdom CK GROUP Full time

    CK Group are recruiting for a Senior Scientist with a protein analytics background, to join a biotechnology company at their site in Abingdon on permanent basis. **The Company**: A TCR biotechnology company with a focus on developing and commercialising a new generation of transformative medicines. Their therapeutic focus is in oncology, infectious and...

  • Scientist IV, Analytical Development

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom Oxford BioMedica (UK) Limited Full time

    Job description: We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you. We are currently recruiting for a Scientist IV to join the Analytical Development and Technologies Group. The purpose of this role is to plan, execute and report experiments or analytical...