Barrington James
VP Analytical Development
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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
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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
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