CMC Development of Biopharmaceuticals, such as
Cell line development including establishing cell banks,
Fermentation & purification process development, including scale up,
Formulation development (liquid, freeze-dried & vaccine formulation),
Analytical development and characterisation,
Manufacturing of cGMP batches for Clinical Trials,
Process Risk Assessment, Process Characterization / Process Qualification and Process Validation
Review CMC sections of regulatory documents such as IMPDs, INDs and Comparability Reports
CMC Development Strategy and Planning, such as
Project Management,
Developing Integrated Project Plan (non-Clinical, Clinical, CMC, Regulatory, Commercial),
Optimization of manufacturing processes & Scale-up,
Technical Due Diligence activities - evaluation of development projects / manufacturing facilities
Identification, evaluation and contract negotiation with CDMOs - Drug Substance and Drug Product,
Managing all technical operations at CDMOs - including trouble-shooting,
Supporting interactions and meetings with Regulatory Authorities