Senior Biologics Product Development Specialist

This is a key hire for a biopharmaceutical organization with over 10 years of experience in developing therapies using monoclonal-antibodies. The company focuses on offering antibody-based medicine to patients globally, targeting oncology, infectious disease, and haematology.

The successful candidate will be responsible for leading the analytical development of injectable biologics, including vials, prefilled syringes, and auto-injectors. This role requires strong expertise in CMC (Chemistry, Manufacturing, and Controls) strategy and authoring for drug development through commercialization worldwide.

The ideal candidate should possess :

• Experience in CMC specialist roles, particularly in drug product development and manufacturing of injectable biologics.
• Proven track record in leading US (BLA) and EU (MAA) CMC strategy and authoring for global drug development and commercialization.
• Method validation and analytical development study expertise.
• Bio-similarity studies experience.

The organization offers support for relocation and visas for the right candidate, providing opportunities for professionals outside Europe to join their team and contribute to groundbreaking research in the field of biologics.