· Conducts review of technology transfer documents and pre-work for manufacturing site transfers, prepares site-transfer strategy documents, and participates in submission strategy discussions
· Assesses the suitability of existing CMC documents for site transfers, authors agree on CMC updates, identifies module 1 special documentation owners, and completes required peer reviews
· Proactively identifies and mitigates CMC and quality risks associated with site transfers, supports contingency planning, and participates in post-publishing reviews prior to dispatch