VP Analytical Development

The Opportunity

A well-funded biologics organisation is looking to appoint a VP, Head of Analytical Science & Quality to join their senior leadership team. This is a high-impact role with full ownership of the analytical and quality function, supporting a pipeline spanning innovative antibody therapeutics and biosimilar programmes.

The Role

• Executive accountability for Analytical Science and Quality across the full product lifecycle, from early development through to commercial manufacturing
• Shaping and driving the analytical and quality strategy in close partnership with CMC, Regulatory Affairs, and Manufacturing leadership
• Full ownership of the QMS, covering change control, deviations, CAPA, and batch review, ensuring GMP/GLP compliance across internal and external sites
• Oversight of method development, validation, and characterisation strategies for antibody and biosimilar molecules
• Leading analytical similarity and comparability programmes in support of biosimilar development
• Managing quality oversight of CDMOs and CMOs, including audits and supplier qualification
• Serving as the senior quality and analytical spokesperson in regulatory agency interactions and inspections (FDA, EMA, MHRA)
• Building, mentoring, and scaling a multidisciplinary team across analytical science and quality

The Person

• Significant senior leadership experience within biologics, with a background spanning both analytical development and quality
• Hands-on exposure to antibody programmes and/or biosimilar development
• A track record of leading teams through regulatory inspections and agency interactions
• Comfortable operating at executive level with strong influencing and communication skills
• Thrives in a dynamic, growth-oriented environment and brings both scientific credibility and commercial awareness