Biopharma Analytical Development Group Lead

Adepto Technical Recruitment Ltd; Greater London; Presencial; GBP 90.000 - 130.000; Jornada completa

Descripción de la vacante

A Group Leader Analytical Development is being sought in Middlesex for a permanent role within a leading biopharma setting. You will lead method development, transfer and regulatory-compliant analytics across biosimilar programs.

You will guide a team of scientists, set strategy for advanced characterization and collaborate with QA, Regulatory and external partners to ensure high-quality data and successful submissions.

Formación

• PhD in biological science or analytical chemistry is required; biosimilar experience desirable.
• Strong background in biologics characterization and impurity analysis.
• Proven leadership of analytical development teams in biopharma.
• Experience with regulatory interactions and CMC-related reports.

Responsabilidades

• Lead analytical development group for method development and transfer.
• Set technical strategy and drive Right First Time culture.
• Provide SME input in cross-functional reviews and regulatory discussions.
• Oversee budgetary planning and external collaborations (CROs).
• Mentor and develop a high-performing team focused on scientific excellence.
• Identify new technologies to advance analytical workflows and product characterization.

Conocimientos

Leadership

Biosimilar development

Biologics analytical techniques

Statistical analysis

Stakeholder management

Cross-functional collaboration

DOE (Design of Experiment)

Problem solving

Educación

PhD in biological science or analytical chemistry

Herramientas

HPLC

CESDS

cIEF

LCMS

CD

DOE tools

Descripción del empleo

A Group Leader Analytical Development is being sought in Middlesex for a permanent role within a leading biopharma setting. You will lead method development, transfer and regulatory-compliant analytics across biosimilar programs.

You will guide a team of scientists, set strategy for advanced characterization and collaborate with QA, Regulatory and external partners to ensure high-quality data and successful submissions.