Generate:Biomedicines
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Biotech
Lead strategy and execution of analytical development and quality control for protein therapeutics across a fully outsourced model. Build and manage a senior team, oversee method lifecycle, release and stability testing, specifications, comparability, regulatory submissions, GMP readiness, CDMO and contract lab oversight, investigations/CAPAs/OOS management, inspection readiness, and resource/budget planning to enable late-stage development and commercialization.
