Interface with key stakeholders,including external CMOs, to manage the development of manufacturingand QC procedures for bioconjugates in compliance with allapplicable GMP regulations.
Manage thedevelopment and validation of manufacturing procedures asrequired.
Manage the development and validationof non-compendial QC procedures asrequired.
Generate development, validation,method transfer, and various other types of protocols andreports.
Support regulatory filings viacompletion of CMC sections for INDs, NDAs, BLAs, and foreignequivalents.
