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.
Zymeworks Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
