Senior Tech Transfer Program Manager - PET USCAN

Job Description SummaryResponsible for project operations and programs supporting the growth of PET CMO & supply chain network in USCAN, including standardization, quality management, document management, methods creation and maintenance, process improvement and tools for the project management function. Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team. Has significant input into priorities. Guided by professional practices and policies that are shaped by the role. The role has moderate autonomy, requiring high levels of operational judgment.

Job DescriptionPosition Summary:

Responsible for all aspects of technical transfer projects including but not limited to: implementation and execution of project plans; developing and managing timelines and budgets; interfacing with customers and providing regular status updates; working cross functionally to ensure successful product launches; coordinating resources across departments and sites; establishing priorities for resource allocation; identifying and mitigating risks; communicating project goals and results to internal and external stakeholders; creating training materials and conducting trainings; maintaining documentation related to project activities, protocols, procedures, and equipment; performing audits as needed; complying with regulatory requirements related to medical device manufacturing, testing, labeling, and safety; and adhering to quality system regulations.

Technology Transfer Management:

• Oversee the end-to-end management of a portfolio of 45+ complex technology transfers, ensuring smooth transitions from R&D to cGMP manufacturing across a network of 40+ sites.
• Collaborate with internal teams (R&D, Quality, Regulatory, Supply Chain, etc.) and external Contract Manufacturing Organizations (CMOs) to ensure successful transfer and scale-up of manufacturing processes.
• Develop and execute detailed project plans for each technology transfer, including timelines, resource requirements, risk assessments, and milestones.

Continuous Improvement and Optimization:

• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the technology transfer process, leveraging industry best practices and lessons learned from past projects.
• Identify opportunities for process optimization and scalability, aiming to streamline technology transfers across multiple sites and CMOs.

Budget and Resource Management:

• Develop and manage project budgets, ensuring efficient use of resources, and maintaining cost controls across all technology transfer projects.
• Ensure proper allocation of resources, including personnel, materials, and equipment, to meet project needs and timelines.

 
Required Requirements:

• Bachelor’s degree in Engineering or equivalent field required.
• 5+ years relevant work experience, preferably within Medical Devices/Pharmaceuticals industry completing tech transfers.  
• Strong understanding of GMP/GDP practices.  
• Experience working with 3rd party vendors and contractors.  
• Strong communication skills, both written and verbal.  
• Demonstrated leadership skills with ability to motivate cross functional teams.  
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).  
• Excellent organizational skills with attention to detail.  

Preferred Skills & Experience: 

• Knowledgeable of Lean Manufacturing principles.  
• Prior experience in process development, technology transfer, and/or new product introduction.  
• Understanding of basic physics and engineering concepts.  
• Experience with Six Sigma methodologies and tools.  
• Experience with automation systems and equipment.    
• Ability to travel domestically and internationally approximately 20% of time.  

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Additional Information

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.