Head of Analytical Development

Discover International; Deutschland; Vor Ort; EUR 120.000 - 170.000; Vollzeit

Zusammenfassung

Discover International in Germany seeks an experienced analytical development leader to build and oversee analytical capabilities supporting our biologics pipeline.

You will lead analytical development from early development through commercialization, overseeing method development, validation, transfer, stability and product characterisation, and establishing analytical strategies for drug substance and drug product.

Qualifikationen

• PhD or MSc in a relevant scientific field.
• 10+ years' experience in analytical development of biologics/biosimilars.
• Proven expertise in protein characterization and analytical technologies.
• GMP experience and regulatory CMC documentation exposure.

Aufgaben

• 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.

Kenntnisse

Analytical development leadership

Biologics analytical characterization

Team leadership

CRO/CDMO management

Ausbildung

PhD or MSc in Analytical Chemistry / Biochemistry / Biotechnology / Pharmaceutical Sciences

Jobbeschreibung

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.