Lead Project Manager - CMO Tech Transfers

1w1 week ago

GE HealthCare

Arlington Heights, US · Full-time · $112,000 – $168,000

About this role

The Lead Project Manager leads and supports technology transfer projects for the growth of PET CMO and supply chain network in USCAN. This role ensures successful scale-up, validation, and commercial readiness of drug products. It maintains compliance with regulatory standards and company quality systems while requiring strong technical understanding and cross-functional leadership.

Day-to-day involves managing end-to-end tech transfer projects for PET drug product manufacturing at CMOs. Develop detailed project plans, timelines, and resource allocation strategies. Supervise early-phase activities like document management, approvals, and meeting cadence, refining processes based on feedback.

Collaborate with stakeholders to define project goals, scope, deliverables, and success metrics. Work with Process Development, Quality Assurance, Regulatory Affairs, and MSAT teams for robust transfer packages. Manage complex external partnerships with CMOs, ensuring alignment with regulatory, quality, and operational requirements.

Identify and mitigate risks related to technical feasibility, regulatory compliance, and commercial readiness. Drive lessons learned and best practices for future tech transfers. Support process optimization across the external manufacturing network.

Requirements

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
Technical expertise in pharmaceutical manufacturing
CMO/CDMO experience

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 including document management, approvals, and meeting cadence
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
Support scale-up activities, process validation, and commercial production readiness
Identify and mitigate project risks and ensure adherence to GMP and Part 212 compliance