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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...
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...
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...
Manages cross-functional project teams to develop improvement solutions for the assigned projects or initiatives
Supports the maintenance and updating of SOPs and business guidelines owned by CDO
Interacts and educates CDO teams and external...