PET Quality Manager
1 month ago
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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