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Head of Analytical Development

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We are seeking an experienced analytical development leader to build and oversee analytical capabilities supporting our biologics pipeline.

Key responsibilities:

  • Lead analytical development for biologics from early development through commercialisation.
  • Oversee method development, validation, transfer, stability and product characterisation.
  • Establish analytical strategies for drug substance and drug product.
  • Support CMC activities, regulatory submissions and health-authority interactions.
  • Manage external analytical partners, CROs/CDMOs and laboratory activities.
  • Build and develop the analytical team, laboratories and technical capabilities.
  • Provide expertise in investigations, comparability, OOS/OOT and analytical troubleshooting.

Your background:

  • PhD/MSc in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences or similar.
  • 10+ years' experience in analytical development of biologics/biosimilars.
  • Strong expertise in protein characterisation and analytical technologies.
  • Experience with GMP, method validation/transfer and regulatory CMC documentation.
  • Proven scientific and people leadership experience.
  • Fluent English; German is advantageous.

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