Head of Biotesting | Head of Biotesting (m/w/d)
Roche Diagnostics GmbH
Job Summary
This leadership role involves heading the Biotesting organizational unit (approx. 45 employees across 3 lab groups) within Sterile Drug Product Manufacturing (SDPM) in Mannheim, focusing on bringing medicines to patients quickly and efficiently. The Head of Biotesting is responsible for disciplinary leadership, ensuring compliance with all legal and regulatory requirements (including AMG, AMWHV, GMP, and IFSG) related to Bioassay and Microbiology. Day-to-day tasks include establishing and tracking goals for Biotesting and QC, overseeing budget and quality targets, and driving continuous process optimization, digitalization, and automation. The ideal candidate possesses a natural science degree (e.g., Biology) with expertise in Microbiology/Cell Biology, extensive professional experience (7-10 years) in a GMP production environment, and proven leadership skills, acting as a coach and catalyst for employee development. This position is attractive as it offers a chance to significantly impact patient health outcomes within a major pharmaceutical company committed to innovation and organizational change.
Required Skills
Education
Completed natural science degree (e.g., Biology) with expertise in Microbiology/Cell Biology
Experience
- 7-10 years of professional experience in a GMP production environment, preferably in sterile production or microbiology
- 7-10 years of disciplinary leadership experience
- Experience managing regulatory inquiries and inspections
- Experience in planning and conducting relevant activities (Release/Stability Testing, EMT, IPC)
Languages
Additional
- Primary location is Mannheim, Germany; Must possess expert knowledge of cGMP relevant to the pharmaceutical industry.
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