Principal Scientist, Tech Ops (Tech Transfer and Outsourcing)

Define and execute transfer strategies, protocols, acceptance criteria, and readiness assessments to ensure successful implementation at receiving sites.

Serve as the primary technical point of contact for external partners, including CDMOs and contract laboratories, ensuring alignment on technical expectations, timelines, and quality standards.

Provide scientific oversight of outsourced activities, including issue resolution, deviation investigations and performance monitoring.

Support preparation, review, and defense of CMC‑related regulatory documentation associated with tech transfer, outsourcing, and lifecycle changes.

Provide scientific input to regulatory interactions, including responses to health authority questions related to transferred technologies.

Support post‑approval lifecycle activities, including site additions, method updates, and continuous improve...