CMC Project Leader - 6 month contract Nr ref.: /JOBS.pl An excellent opportunity has arisen for a CMC Project Manager to join an independent research-based biotechnology company on a 6 month contract basis. The ideal candidate will have a strong CMC and Biologics background - this is essential! Responsibilities:· Alignment of the CMC development strategy· Identification and risk assessment of the quality attributes · Monoclonal antibody experience would be beneficial· Project planning, monitoring and coordination of subcontractors · Support for demand planning and coordination of the packaging / labeling by the external partner · Creation, review and approval of label texts · Preparing the release of samples by the Qualified Person · Organization of temperature controlled transports to study centers and the country-depot · Evaluation of the transport temperature and processing variations · Preparing and reviewing SOPs Experience Required:· Scientific degree · CMC experience in the development of Biologics · At least 5 years of professional experience in production of investigational medicinal products· Expertise in project management, quality management and risk management · Excellent knowledge of GCP and / or GMP requirements for clinical test samples · Organizational skills, communication skills and independent and structured way of working · Very good English language skills, verbal and written For further details about this role, please contact Tim Barratt on (0) or email Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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