External Manufacturing Franchise Project Manager

GE HealthCare

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About The Position

External Manufacturing Project Manager – Radiopharmaceuticals (PET) We are seeking a highly skilled and experienced External Manufacturing Project Manager to lead and execute projects across our external manufacturing network, with a focus on PET radiotracer production. This role requires strong expertise in GMP manufacturing, regulatory frameworks (including 21 CFR 212 and 211), and radiopharmaceutical operations. The ideal candidate will bring experience in working with Contract Manufacturing Organizations (CMOs), radiopharmacies, and cross-functional teams, along with a solid understanding of supply chain, logistics, change control, and manufacturing technologies. This position is responsible for driving the efficient, predictable delivery of strategic initiatives across the radiopharmaceutical external manufacturing network, ensuring alignment with quality, regulatory, and business objectives.

Requirements

• Bachelor’s degree in engineering, Pharmaceutical Sciences, Chemistry, or a related field
• Minimum 5 years of experience in pharmaceutical manufacturing or technical operations
• At least 3 years of project management experience, preferably in regulated environments
• Strong knowledge of GMP, regulatory requirements (including 21 CFR 211 and 212), and validation principles
• Experience working with CMOs and external manufacturing networks
• Excellent communication, stakeholder management, and negotiation skills
• Strong organizational and problem-solving abilities
• Proficiency in project management tools (e.g., MS Project, Smartsheet)
• Willingness and ability to travel up to 10% with advanced notice

Responsibilities

• Lead technical and operational projects related to PET drug product manufacturing across internal teams and external CMO partners
• Define project scope, objectives, milestones, risks, stakeholders, and resource requirements
• Develop and maintain comprehensive project plans, timelines, and resource strategies
• Continuously assess and refine project scope based on data, insights, and stakeholder feedback
• Identify, manage, and mitigate project risks while tracking success metrics
• Ensure alignment with regulatory, quality, and operational standards
• Collaborate with CMOs and cross-functional External Manufacturing teams (EML) to drive: Clear project and initiative scoping Milestone planning and execution Progress tracking across internal and external stakeholders Risk identification and mitigation Project reporting and governance Change management execution
• Manage a portfolio of external manufacturing projects supporting Radiopharmaceutical franchise objectives, including: GMP change control management (internal and CMO-driven) Manufacturing network changes (e.g., new equipment, capacity expansions) to meet demand and S&OP forecasts Implementation and management of pharmacy, customer, and commercial communication processes Development of data and business analytics capabilities Execution of cross-functional initiatives across the CMO network Additional PET-related external manufacturing projects as business needs evolve

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