QA Scientist

Orano Med has developed new processes for producing high‑purity lead‑212, a rare radioactive isotope that is at the heart of promising nuclear‑medicine research. The innovative targeted alpha therapy (TAT) approach recognizes and destroys cancer cells while sparing nearby healthy cells. Orano Med LLC is hiring a Quality Scientist to help ensure that drug products, manufacturing processes, and quality systems meet regulatory, safety, and performance standards from early development through clinical phase 2.

The role will be based in Plano, TX, and will involve collaboration with manufacturing, R&D, and quality teams.

• Conduct thorough technical review and approval of raw data, chromatograms, calculations, instrument audit trails, and analytical reports generated by QC analysts to verify accuracy, completeness, and compliance.
• Lead continuous improvement activities for the verification/qualification/validation program to ensure efficiency, effectiveness, and regulatory compliance through trend analysis of analytical data.
• Conduct effective in‑depth investigations, driving efforts to reduce non‑conforming issues and implement preventive measures.
• Technical review and approval of transfer and validation documentation and technical review of all data generated in accordance with FDA regulations/guidelines.
• Review, analyze, and assess manufacturing processes, R&D recommendations, quality procedures and regulatory guidance to initiate product quality improvements.
• Generation, review, approval and maintenance of cleaning validation activities.
• Perform complex tasks to ensure delivery of high quality of products and processes from design through manufacturing.
• Other duties as assigned.

• Bachelor's of Science (or higher) in Chemistry or other related field
• 7+ years experience in Pharmaceuticals
• 5+ years experience as a Quality Engineer

• Strong experience performing technical review of analytical data
• Experience writing SOPs and other associated GMP documentation
• In‑depth knowledge of cGMP, GLP, FDA/EMA regulations, ICH guidelines, USP/EP pharmacopeial methods, and data integrity principles.
• Proficient in Microsoft Office, Excel, and Power Point
• Excellent technical writing and verbal communication skills.
• Strong organization skills and attention to detail.
• Able to easily switch between multiple ongoing projects, adjusting priorities based on business needs.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. This position requires a pre‑employment background check and drug screening. Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company‑sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status.