Interface with key stakeholders, including external CMOs, to manage the development of manufacturing and QC procedures for bioconjugates in compliance with all applicable GMP regulations.
Manage the development and validation of manufacturing procedures as required.
Manage the development and validation of non-compendial QC procedures as required.
Generate development, validation, method transfer, and various other types of protocols and reports.
Support regulatory filings via completion of CMC sections for INDs, NDAs, BLAs, and foreign equivalents.
