Product Transfer Project Manager

cGMP Consulting•North Chicago, IL

1d•$95,000 - $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.
3-5 years’ experience in a GMP manufacturing environment, including project management. Must be familiar with regulatory (FDA) requirements.
Expertise in one or more of the following areas: validation, qualification of aseptic filling or formulation equipment/processes, qualification of component preparation equipment/processes, and packaging.
Advanced critical thinking and technical writing skills.
Strong organizational, communication, and interpersonal skills.

Responsibilities

Provide strategic direction for the program, ensuring alignment with business objectives and lifecycle management.
Lead and coordinate high-performing, cross-functional teams; including Quality, Regulatory, Manufacturing and Process Engineers.
Serve as liaison between internal and external teams, clarifying requirements, timelines, and handoff deliverables.
Track and report project milestones and key metrics to stakeholder, enduring transparency and alignment.
Facilitate meetings with TPM counterparts to address challenges, resolve issues, and ensure project objectives are met.
Oversee documentation transfer, verification and alignment of processes, ensuring all Regulatory, Quality and compliance standards are met during the transition.
Mitigate risks, resolve issues and develop contingency plans to keep deliverables on track.
Perform additional tasks or duties as assigned by management.