Job Description Summary

The Head of Manufacturing Sciences and Technology (MST) for Radiotracers will lead the technical operations and scientific oversight of the manufacturing of radiotracers ensuring compliance with 21 CFR 212 and board of pharmacy regulations. This role will involve close collaboration with contract manufacturers radiopharmacies and process development teams to ensure the successful tech transfer troubleshooting of equipment and process issues and overall product quality and safety. The ideal candidate will drive the of technical and product risk assessments manage the troubleshooting of technical issues and lead efforts to continuously improve manufacturing processes.

Job Description

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 scaleup 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 crossfunctional 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 processrelated 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 highperforming 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 Masters or Bachelors 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 problemsolving critical thinking and troubleshooting skills.
  • Proven ability to lead crossfunctional 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 teambuilding skills.
• Detailoriented 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.

For U.S. based positions only the pay range for this position is $190960.00$286440.00 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.

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.