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cGMP Consulting Inc. · 5 days ago

NPI Project Manager

North Chicago, IL

Full-time

Onsite

Mid, Senior Level

4+ years exp

cGMP Consulting Inc. specializes in providing expert validation, qualification, and compliance services to the life sciences industry. They are seeking a motivated NPI Project Manager to lead multiple product transfers to Third Party Manufacturers, overseeing the manufacturing and packaging process handover.

Pharmaceutical

Growth Opportunities

Responsibilities

Lead all aspects of NPI projects from strategic decisions, stakeholder management, scheduling, team meetings, budget, communications, and supplier / customer management

Responsible for providing technical input, leading to shape the overall strategies for the front-end planning, due diligence and technical feasibility assessments for potential New Product Introductions

Set and lead NPI site program strategy including stage and gate meetings, timelines to meet program objectives

Work with Site Senior Management in the development and execution of the project development plan and governance body deliverables. Lead Governance Board Meetings

Develop and assess cost and resource projections for potential new business development opportunities and serve as point of contact

Ensure consistency and compliance across all aspects of NPI programs

Effective NPI projects oversight to ensure on time delivery of project(s) deliverables

Perform additional tasks or duties as assigned by management

Qualification

GMP manufacturing experienceTechnical transfer expertiseFDA regulations knowledgeDrug development processProject management skillsCritical thinkingTechnical writingOrganizational skillsCommunication skillsInterpersonal skills