Senior Analytical Development Manager

1 month ago

Abingdon, Oxfordshire, United Kingdom Immunocore Full time
About the Role:

As a key member of our Analytical Development team, you will be responsible for leading the development and implementation of analytical methods for our late-stage biopharmaceutical drug portfolio. Your expertise in CMC development will be instrumental in ensuring the quality and integrity of our products.

Key Responsibilities:
  • Develop and implement analytical methods for biopharmaceutical drug substances and drug products.
  • Lead the analytical team responsible for assay development and validation, and technical transfer of assays to external contract manufacturers.
  • Contribute to regulatory submissions, ensuring the integrity and regulatory compliance of CMC analytical data.
  • Oversee the development of analytical methods to support drug substance and drug product release and stability testing.
  • Manage assay development and validation, and technical transfer of assays to external contract manufacturers that comply with Good Manufacturing Practice (GMP).
  • Write and review CMC analytical sections of regulatory submissions.
  • 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.
  • 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.

Requirements:
  • Significant experience of all analytical aspects of biopharmaceutical CMC development.
  • 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).
  • 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.
  • 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.

About Immunocore:

Immunocore 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 recognized 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.

  • Senior Scientist in Analytical Method Development

    7 days ago

    Abingdon, Oxfordshire, United Kingdom Replimune, Inc. Full time

    Job Overview:Replimune, Inc. is seeking a Senior Scientist to join our team at our Milton Park location. The successful candidate will be responsible for developing and optimizing analytical methods to evaluate drug substance and drug product from preclinical through late phase clinical development.About the Role:The Senior Scientist will manage the...

  • Analytical Development Lead

    3 weeks ago

    Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Role Summary:The successful candidate will lead CMC analytical development activities from late stage to market application, managing the analytical team responsible for biopharmaceutical assay development and validation, and technical transfer of assays to external contract manufacturers.Main Responsibilities:Contribute relevant CMC analytical data to late...

  • Senior Scientist

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Job SummaryThe Vector Process & Analytical Development team at Adaptimmune is seeking a Senior Scientist to support the development of our Lentiviral Vector manufacturing process and analytical assays. The successful candidate will design and execute analytical development projects to advance our understanding of Adaptimmune's lentiviral vector products.The...

  • Senior Scientist

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Therapeutics plc Full time

    Job SummaryWe are seeking a highly skilled Senior Scientist to join our Vector Process & Analytical Development team at Adaptimmune Therapeutics plc. The successful candidate will be responsible for designing and executing analytical development projects to advance our understanding of lentiviral vector products.Key ResponsibilitiesPlan, design, conduct,...

  • Scientist - Vector Process & Analytical Development

    4 weeks ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Key ResponsibilitiesConducting lab work to progress the company's objectives.In collaboration with other team members, logistically plan, analyse, summarise and record experimental results, and maintain relevant databases and records.Participating in group and project meetings and discussionsRoutine lab maintenanceQualifications & ExperienceUndergraduate...

  • Vector Analytics Lead Scientist

    2 weeks ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Senior Scientist Job DescriptionThe Senior Scientist will play a key role in supporting the Vector Analytical Development function at Adaptimmune.About UsWe are a fully integrated cell therapy company with four biotechnology hub locations in the U.K. and U.S. Our comprehensive capabilities include preclinical research, clinical development, translational...

  • Senior Research Scientist, Lentiviral Vector Development

    4 weeks ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Job SummaryThe Vector Process & Analytical Development team at Adaptimmune is focused on the development of Lentiviral Vector manufacturing process and the development and qualification of analytical assays used for Lentiviral Vector characterisation and release.Key ResponsibilitiesThe Senior Scientist will support the Vector Analytical Development function...

  • Research Scientist

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Therapeutics PLC Full time

    Associate Scientist - Vector Process & Analytical DevelopmentAdaptimmune Therapeutics PLC is a leading biotechnology company focused on developing innovative cell therapies. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and...

  • Senior Programme Manager

    4 weeks ago

    Abingdon, Oxfordshire, United Kingdom UK Atomic Energy Authority Full time

    Job DescriptionAs a key member of the RACE division at UK Atomic Energy Authority, we are seeking a highly skilled Senior Programme Manager to lead our programme delivery efforts.The successful candidate will be responsible for coordinating and managing multiple projects, ensuring timely delivery and exceeding customer expectations.Key...

  • Senior Environmental Manager

    4 weeks ago

    Abingdon, Oxfordshire, United Kingdom RPS Group Full time

    Senior Environmental ManagerWe are seeking an experienced Senior Environmental Manager to join our Environment & Infrastructure Team at RPS Group. As a key member of our team, you will be responsible for leading the management and delivery of environmental projects across the UK, working closely with clients to obtain environmental consents and manage...

  • Senior Business Development Manager

    1 month ago

    Abingdon, Oxfordshire, United Kingdom https:jobs-redefined.cositemap Full time

    Are you a seasoned business development professional looking to drive growth and revenue in the education sector?We're seeking a Senior Business Development Manager to join our team at RM, a pioneer in education technology since 1973.As a key member of our Global Growth Solutions team, you will be responsible for executing our growth strategy across the...

  • Senior Stability Program Manager

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Hobson Prior Full time

    Job Summary: We are seeking a highly skilled Senior Stability Program Manager to join our team at Hobson Prior International Ltd. In this role, you will be responsible for managing and maintaining a stability program, ensuring compliance and overseeing sample management. You will also provide expert input into regulatory submissions and support...

  • Senior Business Development Manager

    4 weeks ago

    Abingdon, Oxfordshire, United Kingdom RM Education Limited Full time

    Unlock Your Potential with RM Education LimitedWe are pioneers of education technology, and our mission is to enrich the lives of learners worldwide. As a Senior Business Development Manager, you will play a key role in executing our growth strategy across the assessment sectors.Key Responsibilities:Lead and drive business development opportunities to...

  • Senior Business Development Manager

    1 month ago

    Abingdon, Oxfordshire, United Kingdom Evotec Full time

    Business Development OpportunityEvotec is seeking a seasoned Business Development professional to drive strategic partnerships in Europe. The ideal candidate will report to the Head of Discovery Business Development, Europe, and be responsible for driving business development strategy within the territory in close partnership with the EVP & SVP BD,...

  • Senior Quality Control Manager

    4 weeks ago

    Abingdon, Oxfordshire, United Kingdom Hobson Prior Full time

    Hobson Prior is seeking a Senior Quality Control Manager to lead their QC Stability team. In this role, you will oversee the development and implementation of stability programs, ensuring compliance and sample management. You will also provide expert input into regulatory submissions and support troubleshooting assays to drive continuous improvement.Key...

  • Senior Bioprocessing Specialist

    1 week ago

    Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Job DescriptionAn exciting opportunity has arisen for a highly motivated and skilled Senior Bioprocessing Specialist to join our Vector Process & Analytical Development team at Adaptimmune.

  • Senior Manager, Quality Control Stability

    1 month ago

    Abingdon, Oxfordshire, United Kingdom https:jobs-redefined.cositemap Full time

    Replimune is revolutionizing cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. The company is seeking a Senior Manager, Quality Control Stability to set up and maintain a compliant stability program and regulatory submissions in a clinical and commercial setting.Key Responsibilities:Oversee routine and...

  • Senior Business Development Lead

    3 days ago

    Abingdon, Oxfordshire, United Kingdom RM Education Limited Full time

    Business Development Opportunities abound at RM Education Limited as we seek a Senior Business Development Lead to drive revenue and growth profit. Reporting to the Head of Global Growth Solutions, this key role plays a critical part in the execution of our growth strategy across assessment sectors. Key responsibilities include managing a team of up to 4...

  • Data Assistant

    4 weeks ago

    Abingdon, Oxfordshire, United Kingdom Taylor and Francis Full time

    Job DescriptionTaylor & Francis is seeking a highly organized and detail-oriented Data Assistant to join their Research & Analytics Department. This role will support the provision of data and reports to inform strategic decision making and evidence-based practice across the organization.The Data Assistant will work closely with the team to develop and...

  • Senior Business Development Professional

    4 days ago

    Abingdon, Oxfordshire, United Kingdom M3 Global Research Full time

    About the Opportunity:We are seeking a highly motivated and experienced Senior Business Development Professional to join our team at M3 Global Research. As a key member of our sales team, you will be responsible for identifying and pursuing new business opportunities, building and maintaining strong relationships with our customers, and delivering successful...