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Job description
Overview
Job Summary (Primary function)
As a member of the Incyte Technical Operations (Tech Ops) Global Biologics Development (GBD) group, the Senior Manager, Biologics CMC Project Management provides project management leadership and operational coordination for assigned biologics CMC programs, workstreams, or cross-functional initiatives across development stages. The role partners with the GBD technical lead and cross-functional stakeholders to support translation of program strategy into integrated development plans, track priorities, identify risks and dependencies, and help drive timely, aligned execution across Tech Ops, Discovery, Regulatory Affairs, Quality, Supply Chain, and external partners, including CMOs, CROs, and collaborators. The Senior Manager coordinates cross-functional project team activities, supports scenario planning, governance preparation, and decision-ready project communications, and contributes to consistency, visibility, and execution discipline across assigned programs and project management practices.
Essential Functions of the Job (Key Responsibilities)
Coordinate and help drive cross-functional project team activities for assigned biologics CMC programs, workstreams, or initiatives, supporting alignment on priorities, deliverables, critical path activities, and execution across functions.
Develop and maintain integrated, phase-appropriate project plans that connect CMC, regulatory, technical, and operational activities, and identify dependencies, constraints, and key decision points for review with program/project leadership.
Identify, track, and help escalate risks and issues that could affect scope, timelines, cost, quality, or supply, and support mitigation planning and follow-up actions.
Support resource and budget tracking for assigned programs by maintaining key assumptions, inputs, trade-offs, and program impacts for review with functional and GBD leadership.
Support governance preparation by compiling program status, scenarios, risks, options, and proposed next steps to enable timely and informed decision-making.
Coordinate project management activities with external partners, including CMOs, CROs, and collaborators, to support alignment on plans, deliverables, risks, and execution milestones.
Maintain dashboards, integrated project timelines, and team SharePoint sites, ensuring project information is current, accurate, and decision ready.
Support execution of mid- to late-stage CMC deliverables, including submission-related timelines, readiness activities, and life cycle management tracking for commercial products as needed.
Support onboarding, knowledge sharing, and best practices with peers and junior colleagues as appropriate and contribute to continuous improvement of biologics CMC project management tools and ways of working.
Qualifications/Professional Experience Requirements
Relevant experience supporting or managing cross-functional biologics product development projects, workstreams, or program deliverables is required.
Experience coordinating CMC project activities within the pharmaceutical/biotech industry is required.
Understanding of phase-appropriate CMC development and regulatory submission requirements is preferred.
Strong project management, communication, and facilitation skills with the ability to influence without authority are required.
Experience supporting resource tracking, budget inputs, and program reporting is preferred.
Experience with monoclonal antibody drug development is advantageous.
Minimum of 4-6 years of project management and/or product development experience within the pharmaceutical/biotech industry, or equivalent skills and knowledge, is required.
Degree, such as BS/MS/PhD, in Biological Sciences or related discipline, or equivalent experience.
PMP certification and strong technical background are preferred but not required.
Willingness to travel as needed - occasional international travel to partner(s) and CMO facilities, with accommodations available for individuals with disabilities.
Excellent interpersonal skills with the ability to adapt effectively to changes in organization, structures, and dynamics.
Collaborative, self-motivated, organized, and capable of problem-solving, sound judgment, and managing multiple priorities.
Excellent written, verbal, and presentation skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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