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CMC Project Leader (Freelance) - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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CMC Project Leader (Freelance)

Nr ref.: /JOBS.pl

  • Our Client, an independent research-based biotechnology company based in Mainz, specializing in immunotherapeutics and Oncology is currently hiring a CMC Project Leader on a freelance basis.Your tasks: Alignment of the CMC development strategy in accordance with the overall project strategy to approval Definition of Quality Target Product Profiles Identification and risk assessment of the quality attributes Planning, review and timely supply of multicentre clinical trials with test patterns (monoclonal antibodies) Project planning, monitoring and coordination of subcontractors Ability of parent cooperation with the fields of clinical research and quality-assurance, and various external partners When necessary, supporting planning and coordination of the packaging / labeling by external partners Creating, testing and release of label texts the release of test preparation by the QP Organization of temperature controlled transports to study centers and country depots evaluation of the transport temperature and processing variations Preparation and review of SOPsYour skills:Science StudiesCMC experience in the development of BiologicsAt least 5 years of professional experience in manufacturing of pharmaceuticals or clinical trialsExpertise in project management, quality management and risk managementVery good knowledge of GCP and / or GMP requirements for clinical test samplesOrganizational skills, communication skills and independent and structured way of working Very good English skills in speaking and writingMS-Office For further details please contact; (0) /


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