Lead Project Manager- CMO Tech Transfers

GE HEALTHCARE • Arlington Heights, OH

14d • $108,000 - $162,000 • Remote

About The Position

The Lead Project Manager will lead and support technology transfer projects supporting the growth of PET CMO & supply chain network in USCAN. This role ensures successful scale-up, validation, and commercial readiness of drug products while maintaining compliance with regulatory standards and company quality systems. The position requires strong technical understanding, cross-functional leadership, and expertise in managing complex external partnerships.

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or related field.
• 6+ years in pharmaceutical manufacturing or technical operations, with at least 3 years in project management.
• Proven experience managing tech transfers with CMOs for drug substance or drug product.
• Strong knowledge of GMP, regulatory requirements, and validation principles.
• Excellent communication, negotiation, and stakeholder engagement skills.
• Proficiency in project management tools (MS Project, Smartsheet, etc.)
• Ability and willingness to travel 10% of time with advanced notice.

Responsibilities

• Manage end-to-end tech transfer projects for PET drug product manufacturing at CMOs.
• Develop and maintain detailed project plans, timelines, and resource allocation strategies.
• Supervise early-phase activities (document management/approvals, meeting cadence) and refine processes based on initial findings or feedback.
• Collaborate with stakeholders to define project goals, scope, deliverables, and success metrics.
• Ensure alignment with regulatory, quality, and operational requirements.
• Collaborate with Process Development, Quality Assurance, Regulatory Affairs, and MSAT teams to ensure robust transfer packages.
• Support scale-up activities, process validation, and readiness for commercial production.
• Identify and mitigate project risks related to technical feasibility, regulatory compliance, and commercial readiness.
• Ensure adherence to GMP, Part 212 compliance, and relevant SOPs throughout the transfer process.
• Drive lessons learned and best practices for future tech transfers.
• Support process optimization initiatives across external manufacturing network.

Benefits

• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees