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In close collaboration with our CMO and interdisciplinary project teams you will be responsible for the validation of antibody Drug Substance and Drug Product manufacturing processes including
o Process characterization studies
o Compilation of...
Management of operational QA aspects within the daily collaboration with CMOs during CMC development and GMP manufacturing of late stage projects in close coordination with the QA department and project teams, including
o Review and authorization...
Evaluation of external QC related documents (batch records, test instructions, stability protocols and reports, validation protocols and reports)
Coordination of stability, compatibility and comparability studies
Development and maintenance of...
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Plan, perform and follow-up audits of CROs, external laboratories, clinical trial sites
Hosting and follow-up of authority inspections
Plan, perform and follow-up audits of in house GCP / PV systems including document audits
Write / review...
Establishment of a third party network for commercial secondary packaging and distribution in US and major European countries for MorphoSys’ first commercial product
Establishment of supply chain procedures to enable product launch and supply...
Management of operational RA aspects within the daily collaboration with CMOs and partners during CMC development in close coordination with the RA department and interdisciplinary project teams
Preparation of / contribution to regulatory...