Description
We are looking for a
GMP Team Leader USP/DSP (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Bern region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Supervise activities, personnel (process engineers and technicians) and equipment of the department to meet project demands
- Responsibility for defining objectives and activities related to GMP production within the process development department, as well as responsibility for the outcome
- Assure that data from CTM manufacturing is prepared, analysed, interpreted and retained accurately
- Write, review and approve study plans and study reports
- Participate as the USP/DSP production Subject Matter Expert in regulatory inspections
- Maintain and continuously improve cGMP compliance within USP/DSP area, support maintenance and improvement of cGMP compliance of pilot plant facility with relation to USP/DSP area
- Strong cross-functional interaction with other team leaders, the Development and Investigations team and with other site departments as well as with the Scientific Leads at the sites in Bern
Your qualifications
- Master's degree with in-depth relevant experience in CMC development of biologics
- Knowledge and experience in cGMP manufacturing of CTM and/or commercial drug substance
- SME experience in the USP/DSP area (anaerobic fermentation, centrifugation and ultra filtration), including pilot scale and technology transfer
- Profound experience in leading teams
- Knowledge and interpretation/implementation ability regarding cGMP and current regulatory compliance guidelines
Skills:
- Qualification/validation specialist
Keywords: GMP Teamleader USP DSP SME anaerobic fermentation centrifugation and ultra filtration CMC development of biologics