PET Quality Manager

1 month ago


Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time
Job Summary

Lantheus Medical Imaging Inc is seeking a Quality Assurance Specialist to support the PET Supplier Quality Team. The ideal candidate will have experience in CMC authoring and regulatory submissions.

Key Responsibilities:

  • Author and review CMC sections of regulatory filings for radiopharmaceuticals.
  • Collaborate with technical subject matter experts to review and interpret data.
  • Manage project activities, assess risks, and develop plans for CMC-related projects.
  • Maintain submission information in relevant CMC systems and track timelines.
  • Provide technical and scientific guidance for completion of complex projects.
  • Prioritize and independently complete assigned workload.
  • Manage and contribute to CMC-related projects and initiatives.

Requirements:

  • Bachelor's degree in a related science discipline.
  • Minimum of 5+ years quality assurance/technical experience in a pharmaceutical/life-science environment.
  • Strong experience authoring CMC regulatory sections, including INDs/CTAs.
  • Demonstrated ability to translate complex information into written reports.
  • Familiarity with regulatory health authority expectations for CMC (Module 3) pharmaceutical applications.
  • Working knowledge of PET Good Manufacturing Practice guidance and FDA regulations.

About Lantheus Medical Imaging Inc:

Lantheus Medical Imaging Inc is a leading provider of innovative diagnostics, targeted therapeutics, and artificial intelligence solutions. We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.



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