1. Tech transfer from internal or external process development. Develop and translate process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment, etc) to ensure successful tech transfer and manufacturing,
2. In support of resolving complex process issues and trouble shootings for PPQ run and clinical manufacturing.
3. In support of process development-related documents for IND or NDA submission.
4. Collaborate with MSAT, Mfg, QA, and QC to set up manufacturing strategy for engineer run and process performance qualification.
5. To achieve some GMP-related files, e.g. risk assessment, master validation plan, comparability study, gap analysis, stability study…. etc.