Für ein international erfolgreiches Pharmaunternehmen in Oberschwaben suchen wir zum nächstmöglichen Eintritt, zunächst im Rahmen der ANÜ

• As Scientist Endotoxin Testing you are responsible for the scientific lead for LER studies and the Center of competence for endotoxins – you coordinate and monitor our LER studies and outsourcing approaches with a professional and scientific support of internal and external partners.
• You prepare GMP and scientific documents (e.g. study reports, clinical dossiers, commercial dossiers) under consideration of  internal guidelines
• You represent the endotoxin lab in audits and project meetings
• In addition you are the first contact and support for LER questions on site and external sites, as well as for external laboratories.
• Living our safety culture (global EHS standards) and support an open creative, innovative, trust worth, continuous learning, proactive culture focused on business goals is one of you key tasks

• PhD in Biology, Biotechnology, Pharmaceuticals or in a related scientific discipline with experience in quality control of the (bio-)pharmaceutical industry or Master with several years of experience in quality control
• Excellent knowledge in microbiology and GMP-requirements (e.g. pharmacopoeias), regulations and industrial guidelines (e.g. ICH), especially with respect to endotoxin testing, LER effect, method transfer and verification
• Strong experience of endotoxin analytic procedures performed within the (bio-) pharmaceutical industry in the GMP area
• Solid project management and negotiation skills, preferably with multiple years of experience in leading matrix teams
• Excellent problem solving and risk assessment skills
• Fluent in English and German (written and spoken)

Interessiert?

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