Head of Analytical Development
Zurück zu den Treffern
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.
Weitere Stellen
CTA, BTA, MTL / MTLA, MTV oder Biologe (m/w/d) für die Klinische Chemie & Gerinnung
Labor Becker MVZ eGbR
MünchenVollzeit
45.000–65.000 € brutto/Jahr
Chemielaborant / Chemietechniker (m/w/d) in Vollzeit 100% als Service Engineer (m/w/d) im Außendienst in der Region Nordbayern
Metrohm Deutschland GmbH & Co. KG
München und Umgebung+ 1 weitereVollzeit