Specialist Coordinator / Lead for Development & Transfer (Biological and Pyrogenic Analytics) | Fachkoordinator*in / Fachleitung für die Abteilung Development & Transfer (m/w/d)
Labor LS SE & Co. KG
Job Summary
This role is ideal for an experienced scientific professional specializing in biological and pyrogenic analytics, particularly focusing on pyrogenic contamination detection using the Monocyte Activation Test (MAT). The Specialist Coordinator/Lead will guide and mentor laboratory staff during testing, ensure the release of accurate and reproducible results, and prepare findings for decision-making. Key responsibilities include creating development and validation plans and reports for the MAT, conducting training, and supporting departmental leadership with administrative and organizational tasks, such as creating offers, managing statistics, and personnel planning. Candidates must hold a degree (Bachelor, Master, Diploma, or PhD) in a natural science field like Biology or Bioanalytics, possess expertise in GMP-compliant analysis documentation, and have knowledge of biological quality testing for pharmaceuticals or medical devices according to relevant pharmacopoeias and DIN ISO regulations. The position requires a highly motivated, structured, and communicative team player eager to develop independent solutions in a dynamic, innovative, and highly regulated environment.
Required Skills
Education
Successful completion of a degree (Bachelor, Master, or Diploma) in a natural science field (e.g., Biology, Bioanalytics) or a PhD in a relevant area
Experience
- Experience in GMP-compliant execution and documentation of analyses
- Knowledge of biological quality testing for pharmaceuticals or medical devices according to relevant regulations (Pharmacopoeias, DIN ISO regulations)
- Professional experience in quality assurance within a dynamic and innovative environment
Languages
Additional
- Not specified
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