NPI Project Manager

cGMP Consulting•North Chicago, IL

2d•$950,000 - $125,000

About The Position

cGMP Consulting is seeking a motivated and detail-oriented individual to lead multiple product transfers to Third Party Manufacturer (TPM). This individual will be responsible for overseeing the handover of a product's manufacturing and packaging process between the site and client. This senior-level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment. The ideal candidate will excel in leading cross-functional collaboration, troubleshooting, change management, and project completion while demonstrating independence. This candidate should have a strong understand of product transfers, packaging, current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

Requirements

Bachelors’ degree in Engineering, Science, or a related field of study.
4+ years’ experience in a GMP manufacturing environment. Must be familiar with regulatory (FDA) requirements.
Expertise in technical transfer and new product launch within Pharmaceutical Manufacture environment.
Strong knowledge in drug development process and pharmaceutical manufacturing process.
Advanced critical thinking and technical writing skills.
Strong organizational, communication, and interpersonal skills.

Responsibilities

Lead all aspects of NPI projects from strategic decisions, stakeholder management, scheduling, team meetings, budget, communications, and supplier / customer mangagment.
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 NIP projects oversight to ensure on time delivery of project(s) deliverables.
Perform additional tasks or duties as assigned by management.