Lead Project Manager- CMO Tech Transfers jobs in United States
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GE HealthCare · 1 week ago

Lead Project Manager- CMO Tech Transfers

GE HealthCare is a leader in healthcare technology and is seeking a Lead Project Manager to oversee technology transfer projects within their PET CMO & supply chain network. The role involves managing complex projects to ensure compliance and readiness for drug products while collaborating with various stakeholders and maintaining quality standards.

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Growth Opportunities
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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

Qualification

GMP knowledgeTechnical operationsRegulatory complianceProject managementStakeholder engagementCMO/CDMO experienceProcess validationRisk managementCommunication skillsNegotiation skillsLeadership

Required

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

Benefits

Medical
Dental
Vision
Paid time off
A 401(k) plan with employee and company contribution opportunities
Life
Disability
Accident insurance
Tuition reimbursement

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Funding

Current Stage
Public Company
Total Funding
$5.52B
Key Investors
Bill & Melinda Gates Foundation
2024-11-07Post Ipo Secondary· $1.17B
2024-09-12Post Ipo Secondary· $1.29B
2024-02-16Post Ipo Secondary· $1.07B

Leadership Team

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Catherine Estrampes
President and CEO, US & Canada
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Luiz Verzegnassi
President & CEO, Services
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Company data provided by crunchbase