Experienced Scientist

Johnson & Johnson Johnson & Johnson · Pharma · Ringaskiddy, Cork, Ireland

Experienced Scientist role in Biotherapeutics R&D at Johnson & Johnson, focusing on analytical development, testing, method transfer, and validation within a GMP environment. The role involves executing laboratory activities, reviewing results, identifying trends, supporting R&D projects, and ensuring equipment qualification and maintenance. It requires experience in regulatory requirements and GMP settings, with a focus on biopharmaceutical analytical procedures.

What you'd actually do

  1. Performing routine and non-routine analytical testing activities in line with laboratory methods and procedures
  2. Reviewing laboratory test results, where appropriate, and ensuring testing and approvals are completed within agreed turnaround times
  3. Identifying result trends and escalating non-conformances or deviations promptly to the team lead
  4. Supporting the execution of Biotherapeutics R&D projects and development programs as a developing individual contributor
  5. Supporting method transfer and validation activities to ensure methods meet applicable ICH, CFR, USP, and EP guidelines

Skills

Required

  • Bachelor’s, Master’s, or advanced degree in a scientific or technical discipline
  • Experience performing progressively advanced responsibilities at Scientist level
  • Knowledge of FDA, EMA, and other applicable regulatory requirements relevant to biologics and/or pharmaceuticals
  • Experience in GMP or cGMP laboratory environments, including analytical testing, method transfer and validation
  • Demonstrated knowledge of scientific theories, principles, and techniques used in biological or pharmaceutical analytical test procedures
  • Strong written and verbal communication skills
  • Ability to work effectively across functions

Nice to have

  • Experience in Separation Sciences or analytical development within a biopharmaceutical or biologics setting
  • Experience supporting non-conformances, investigations, deviations, and CAPA activities
  • Proficiency with Microsoft Office applications

What the JD emphasized

  • GMP environment
  • analytical testing
  • method transfer and validation
  • regulatory requirements