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.Job Description
Key Responsibilities
Project Leadership & Execution
- 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
Technical Project Management
- 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
Required Qualifications
Education
- Bachelor’s degree in engineering, Pharmaceutical Sciences, Chemistry, or a related field
Experience
- Minimum 5 years of experience in pharmaceutical manufacturing or technical operations
- At least 3 years of project management experience, preferably in regulated environments
Skills & Competencies
- 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)
Travel
- Willingness and ability to travel up to 10% with advanced notice
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
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