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Head of Analytical Development

Discoverintl — Germany · Posted ~3 hours ago

Head Full-time

Skills

Analytical development Biologics Method validation Protein characterization Regulatory support Team leadership Analytical chemistry Biotechnology

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Summary ✨ AI‑Generated

A senior scientific leadership position responsible for establishing and managing analytical development capabilities for biologics. The role includes team building, regulatory collaboration, method development, and technical strategy.

Highlights

Leadership role building analytical capabilities, managing scientific teams, and supporting advanced biologics development programs.

Description

Head of Analytical Development 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. If this position seems interesting, please apply or send a copy of your CV to sam.brown@discoverinternational.com