Senior Manager, Biologics CMC Project Management
Listed on 2026-10-11
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Management
Regulatory Compliance Specialist, Project & Program Management
Senior Manager, Biologics CMC Project Management within Incyte's Tech Ops Global Biologics Development group, leading cross-functional project coordination for biologics development programs across all stages.
Responsibilities- develop integrated project plans
- track dependencies
- identify and elevate risks
- support resource and budget management
- prepare governance materials
- coordinate with external partners like CMOs and CROs.
- Contribute to lifecycle management and submission timelines, ensuring aligned execution and visibility.
4-6+ years supporting biologics product development in pharma/biotech, with experience in CMC project activities and understanding of regulatory requirements.
EducationBS/MS/PhD in Biological Sciences or related.
Skillsstrong project management, facilitation, communication, and influence skills; PMP preferred.
High Valuebiologics (monoclonal antibodies), CMC development, cross-functional coordination, mid-to-late stage development, regulatory submissions, external vendor management.
Work Setuphybrid, with occasional international travel.
We are seeking a motivated Senior Manager, Biologics CMC Project Management to join Incyte in Wilmington, DE, United States.
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