Biologics Development Scientist

hace 1 semana


Barcelona, Barcelona, España Almirall A tiempo completo
Biologics Development Scientist

We are seeking a highly skilled Biologics Development Scientist to join our team at Almirall. As a key member of our Biologics Development group, you will be responsible for leading analytical activities and driving GMP QC activities for antibody-based molecules.

Key Responsibilities:
  • Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs
  • Contribution to the set up and development of in-house/outsourced analytical activities
  • Definition of DS & DP specification according to applicable regulatory guidelines
  • Preparation of technical documents including method development, method validation, transfer protocols, and reports
  • Authoring and review of CMC regulatory analytical submissions documents
Requirements:
  • Master degree or PhD in a relevant scientific area or equivalent
  • Experience with chromatographic and pharmacopeia methods for biologics
  • Experience in establishing specifications
  • Experience in preparing and reviewing relevant filing documentation for regulatory applications
What We Offer:
  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package


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