Lead downstream process development and manufacturing strategy for clinical-stage biotherapeutics, including antibodies, multispecifics, and ADCs, overseeing process development, scale-up, production, and technology transfer with CMOs. Provide technical and regulatory CMC support, manage manufacturing quality and lifecycle activities, author documentation, and coordinate internal and external teams to ensure product supply and delivery timelines. Requires a university degree in science or engineering and at least 8 years of relevant biopharmaceutical process development and GMP operations experience, or an equivalent combination of education and experience. Candidates should have CMO experience, strong knowledge of cGMP and ICH requirements and biological product regulatory compliance, and effective analytical, organizational, and cross-functional collaboration skills; familiarity with QbD, control strategies, multivariate analysis, or DoE is a plus.
Associate Director, Downstream Process Development
Bellevue, Washington, 98004
Full Time
Onsite
$146250 - $224250/yr
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