Lead Project Manager- CMO Tech Transfers

Job Description

Summary 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.

Job Description

Roles and Responsibilities

• Project Leadership & Execution:
• 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.
• Technical Coordination:
• 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.
• Risk & Compliance Management:
• 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.
• Continuous Improvement:
• Drive lessons learned and best practices for future tech transfers.
• Support process optimization initiatives across external manufacturing network.

Required Qualifications

• Education: Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or related field.
• Experience:
• 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.
• Skills:
• 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.)
• Travel: Ability and willingness to travel 10% of time with advanced notice.

Core Competencies

• Technical Expertise in Pharmaceutical Manufacturing
• CMO/CDMO Experience
• Leadership & Influence
• Risk Management
• Regulatory & Quality Compliance

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $108,000.00-$162,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). 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. Additional Information 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 Application Deadline: December 31, 2025 Apply tot his job Apply To this Job