Associate Development Manager

6 days ago

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

We are seeking an experienced Associate Development Manager to lead our CMC analytical development activities from late stage to market application.

As a key member of our Analytical Development team, you will be responsible for managing the analytical team responsible for biopharmaceutical assay development and validation, and technical transfer of assays to external contract manufacturers (CDMO).

You will contribute relevant CMC analytical data to late stage regulatory submissions, ensuring their integrity and regulatory compliance.

Key Responsibilities:

  1. Lead CMC analytical development activities from late stage to market application.
  2. Manage the analytical team responsible for biopharmaceutical assay development and validation, and technical transfer of assays to external contract manufacturers (CDMO).
  3. Contribute relevant CMC analytical data to late stage regulatory submissions, ensuring their integrity and regulatory compliance.
  4. Oversee development of analytical methods to support drug substance and drug product release and stability testing for the Immunocore late stage therapeutic drug portfolio.
  5. Manage assay development and validation, and technical transfer of assays to external contract manufacturers that comply with Good Manufacturing Practice (GMP).
  6. Write/review CMC analytical sections of regulatory submissions.
  7. Plan and lead high impact studies that reduce the risk of drug development projects.
  8. Help define the strategic direction within Analytical Development and CMC department.
  9. Prepare reports and presentations of high quality for project teams, senior management, and collaborators.
  10. Ensure the highest quality and integrity of laboratory work, electronic records, study reports, and regulatory submissions.
  11. Identify and champion new analytical technology opportunities, and lead innovative assay development projects that enhance the drug development process.
  12. Develop and mentor staff to help them succeed and grow.

Requirements

Essential:

  1. Significant experience of all analytical aspects of biopharmaceutical CMC development.
  2. Experience with late stage/commercial biopharmaceutical drug programs, including experience of assay and process validation.
  3. Experience with biopharmaceutical late stage regulatory submissions (e.g. BLA, MAA), knowledge of relevant regulatory guidelines.
  4. Minimum of 2 years relevant experience with people line-management in biopharmaceutical industry.
  5. Experience with managing analytical activities at Contract Manufacturing and Development Organisations (CDMO).
  6. Presented detailed scientific findings to internal and external audiences.
  7. Mentored and coached less experienced colleagues in scientific practices and theory.

Desirable:

  1. Built a network of external scientific contacts as both a contributor and recipient.
  2. Contributed to and influenced the strategic scientific direction within the CMC department and company as a whole.
  3. Managed external scientific projects including input into negotiations and quality agreements.
  4. Quality mindset that values excellence, continued improvement and attention to detail.
  5. Building collaborative relationships, developing, maintaining and strengthening partnerships with others who can provide information, assistance, and support.

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