Carbyne Consulting

CMC Project Manager - Biosimilar - Remote

Posted: 6 days ago

Job Description

Join our Biotech PMO as a CMC Project Manager, driving biosimilar development programs through scale-up and commercialization. You’ll operate within the CMC Coordination Group, ensuring cross-functional alignment across process development, analytical sciences, and manufacturing.🎯 ResponsibilitiesLead end-to-end CMC planning for biosimilar assetsDefine scope, timelines, and deliverables across development stagesAlign technical strategy with regulatory and analytical objectivesManage risk, budget, and critical path activitiesCoordinate tech transfer, validation, and launch readinessSupport lifecycle management and post-approval changes🧠 QualificationsDegree in Life SciencesStrong knowledge of ICH guidelines and GMP complianceExperience in biologics development; biosimilars preferredProven track record in tech transfer and CMC program executionSkilled in project governance, stakeholder management, and cross-functional coordinationPMP certification is a plus; leadership mindset is essentialEU work authorization required💼 What We OfferStrategic role in a global biopharma organizationOwnership of high-impact biosimilar programsCollaborative, science-driven cultureCompetitive packageRemote work setup

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