Found Description
From Mabxience, a company specialized in the development and manufacturing of biosimilar medicines, we incorporated an MSAT DP Technician for our plant in León (Spain).
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Responsibilities
- Technology transfer, implementation and validation of the drug product (DP) manufacturing processes in Fill&Finish CMOs.
- Technical communication with Fill&Finish CMOs.
- Implementation and optimization of DP manufacturing for technical and clinical GMP batches.
- Development of the DP process carried out together with mAbxience R&D department, including process FMEA and risk assessment, process development and process characterisation studies.
- Process validation plan and report and control strategy definition.
- Generation of documents needed for DP manu...