GE HealthCare Head Manufacturing Sciences & Technology 

United States, Illinois 

782988900

Key Responsibilities:

• Leadership and Oversight:
  • Lead and oversee the manufacturing sciences and technology team for radiotracer production in compliance with 21 CFR 212.
  • Provide strategic direction and technical guidance to ensure effective manufacturing of radiotracers.
  • Drive technical excellence within the department and ensure the highest levels of performance and efficiency.
• Collaboration with External Partners:
  • Serve as the primary technical liaison between internal teams and contract manufacturers or radiopharmacies.
  • Lead technical and scientific collaboration to ensure smooth tech transfers, scale-up, and consistent quality production at external manufacturing sites.
  • Ensure that external partners are compliant with applicable regulations and internal quality standards.
• Tech Transfer Management:
  • Lead and manage the tech transfer process for radiotracers, ensuring all aspects of the process, from development to manufacturing, are appropriately transferred, validated, and optimized.
  • Coordinate with cross-functional teams (e.g., Process Development, Quality, Regulatory) to ensure seamless transitions during tech transfers.

• Troubleshooting and Process Optimization:
  • Provide technical leadership in troubleshooting equipment and process-related issues at internal and external sites.
  • Identify and resolve challenges related to production processes, equipment performance, and quality deviations.
  • Lead continuous improvement initiatives to optimize manufacturing efficiency and product quality.
• Risk Management:
  • Conduct technical and product risk assessments for quality deviations and manufacturing issues.
  • Collaborate with quality teams to implement corrective actions, manage risk mitigation strategies, and ensure ongoing compliance with regulatory standards.
  • Support CAPA (Corrective and Preventive Action) activities and investigations related to product quality and process performance.
• Regulatory Compliance:
  • Ensure that all manufacturing processes, including tech transfers and product development, comply with FDA regulations (21 CFR 212), board of pharmacy and other applicable regulatory requirements.
  • Lead the preparation for regulatory inspections, audits, and submissions, ensuring all necessary documentation is in place and compliant with relevant guidelines.
• Team Leadership and Development:
  • Build and lead a high-performing MST team, fostering a culture of collaboration, innovation, and continuous improvement.
  • Mentor and develop team members, ensuring they have the skills and knowledge necessary to meet organizational goals and maintain compliance with industry standards.
• Documentation and Reporting:
  • Oversee the preparation and review of technical documentation, including batch records, reports, validation protocols, and regulatory submissions.
  • Ensure all technical documentation is complete, accurate, and up to date in line with regulatory requirements.

Qualifications:

• Education:
  • PhD, Pharmacy, Master’s, or Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• Experience:
  • Minimum 10 years of experience in the manufacturing or technical operations of radiopharmaceuticals or biologics, with a focus on radiotracers and compliance with 21 CFR 212.
  • Proven experience in managing tech transfers and collaborating with contract manufacturers and external radiopharmacies.
  • Expertise in troubleshooting manufacturing processes, equipment, and resolving technical challenges.
  • Strong experience in conducting risk assessments, CAPA activities, and managing product quality deviations.
• Skills:
  • Strong knowledge of FDA regulations (21 CFR 212), Board of Pharmacy & cGMP compliance.
  • Excellent problem-solving, critical thinking, and troubleshooting skills.
  • Proven ability to lead cross-functional teams and manage external relationships with manufacturing partners.
  • Exceptional communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
  • Familiarity with radiotracer production and related technologies is highly desirable.

Personal Attributes:

• Strong leadership and team-building skills.
• Detail-oriented with a passion for maintaining the highest standards of quality and compliance.
• A collaborative mindset with the ability to navigate complex technical and operational challenges.
• A proactive approach to continuous learning, innovation, and improvement in manufacturing practices.

Additional Information:

• This position may require travel to external manufacturing sites or other relevant locations.