Senior Biologics Product Development Specialist

This is a new hire for an organization with over 10 years of experience in Biologics, focusing on producing therapies using monoclonal-antibodies. The goal is to offer the best antibody-based medicine globally.

They are hiring an experienced CMC Analytical Development Manager who would be responsible for overseeing drug product development and manufacturing of injectable biologics (e.g., vials, prefilled syringes, auto-injectors). The ideal candidate should have expertise in :

• CMC specialist in Drug Product development and manufacturing of injectable biologics.
• Lead US (BLA) & EU (MAA) CMC strategy & authoring for drug development through to commercialization worldwide.
• Experience in method validation, validating analytical development studies.
• Experience with Bio-similarity studies.

The organization is dedicated to finding the right candidate for this role and is willing to support visa's and relocation.