Publié: 19 juin 2024
Lausanne
100%
Durée indéterminée
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Quality Control Lead - NEW
Description
Function
Quality Control Lead
Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage
100 %
Reporting Line
Analytical Development & Quality Control (ADQC) Group Leader AC Immune is a clinical-stage Swiss Biotech Company focused on the development Overview of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases. AC Immune is seeking a highly qualified Quality Control Lead to support its CMC product development programs. The candidate must possess a strong background in Analytical Chemistry or equivalent and must have extensive Quality Control experience, preferably in the (bio)pharmaceutical industry and in the interface with Quality Assurance and Regulatory Affairs functions. - Lead and manage analytical method transfer, qualification and/or validation Job description activities to/at external partner(s) or Contract Research Organizations (CROs), including revision and approval of required documentation, for Drug Products, APIs and raw materials
- Ensure that Release, Characterization and Stability testing by partners or Contract manufacturing Organizations (CMOs) and CROs is performed in compliance with cGMP/GLP/ICH/USFDA/ISO guidelines and aligned with internal and industry quality standards. - Manage and/or support the OOS/OOT/OOE and any other analytical related Deviations, CAPAs, Change Control, etc in close collaboration with QA /RA department and ADQC team.