Lead tech transfer between internal R&D, external CDMOs, and manufacturing.
Lead cross-functional workstreams across PD, analytics, manufacturing, QC/QA, supply chain.
Manage projects: strategy, timelines, risks, external contracts, and status updates.
Author technical docs for tech transfer: process descriptions, specs, SOPs, transfer plans.
Create regulatory-ready QMS/source docs for FDA and global health authorities.
Define CPPs/CQAs and establish phase-appropriate specs with process development.

🎯 Requirements

Degree in chemical engineering/bioprocessing/biological sciences with 5+ years (PhD), 9+ MSc, or 11+ BS.
Cell therapy, pluripotent stem cells, manufacturing, tech transfer, and cGMP exp.
Hands-on experience developing/optimizing cell culture processes.
Aseptic techniques in cell culture.
GMP manufacturing operations experience.
Supervisory/mentoring skills; excellent communication and cross-functional leadership; travel 15-35%.

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