What are the responsibilities and job description for the Quality Scientist position at Orano?
Description
Description
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
Orano Med LLC has opening for Quality Scientist in Plano, TX.
This role ensures the integrity, reliability, and regulatory compliance of analytical methods and their transfers used for drug product testing from early development through Phase 2 clinical manufacturing. The Quality Scientist partners closely with QC, Analytical Development, Manufacturing, and QA teams. Using strong scientific judgment and GMP expertise, this position leads investigations, evaluates analytical trends, drives effective CAPAs, and ensures method qualification, validation, and transfer activities meet FDA, EMA, and global regulatory expectations. Success requires exceptional analytical acumen, meticulous attention to detail, and the ability to translate complex laboratory and process data into compliant, practical solutions that protect product quality and patient safety.
Key Responsibilities
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Minimum Qualifications
Present in the United States for 60 years, Orano USA is a leading technology and services provider to the U.S. commercial and federal markets.
Orano’s activities in the U.S. include developing uranium enrichment facility in Oak Ridge, TN ; packages and transportation of uranium & nuclear fuel assemblies ; fabricating & installing used nuclear fuel dry storage canisters and casks, conducting pool-to-pad used nuclear fuel transfers ; providing solutions to the National Labs and to the Dept of Energy ; and supplying U.S. nuclear energy utilities with uranium, conversion, and enrichment services.
In the nuclear medicine field, Orano Med is at the forefront of research in nuclear medicine and is developing a new generation of targeted therapies against cancer using the unique properties of lead-212.
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.
Description
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
Orano Med LLC has opening for Quality Scientist in Plano, TX.
This role ensures the integrity, reliability, and regulatory compliance of analytical methods and their transfers used for drug product testing from early development through Phase 2 clinical manufacturing. The Quality Scientist partners closely with QC, Analytical Development, Manufacturing, and QA teams. Using strong scientific judgment and GMP expertise, this position leads investigations, evaluates analytical trends, drives effective CAPAs, and ensures method qualification, validation, and transfer activities meet FDA, EMA, and global regulatory expectations. Success requires exceptional analytical acumen, meticulous attention to detail, and the ability to translate complex laboratory and process data into compliant, practical solutions that protect product quality and patient safety.
Key Responsibilities
- Perform thorough technical review of QC analytical data, including raw data, chromatograms, calculations, audit trails, and reports to verify accuracy, data integrity, and method compliance while identifying trends.
- Lead and support analytical method qualification, validation, and transfer activities, including protocol review, data evaluation, receiving site alignment, and adherence to ICH Q2/Q14, FDA, and EMA guidelines.
- Drive continuous improvement of the analytical qualification/validation program through data trending, method performance monitoring, and initiatives to enhance robustness and reduce variability.
- Conduct scientifically sound investigations of analytical deviations, OOS/OOT results, and nonconformances, ensuring robust root cause analysis and effective CAPA implementation.
- Provide technical review and approval of method transfer packages, validation documents, and associated data to ensure regulatory and internal compliance.
- Assess manufacturing processes, method performance, and R&D recommendations to identify risks, propose improvements, and support method optimization and lifecycle management.
- Execute complex quality and analytical tasks to deliver consistent, high-quality data, methods, and processes across the product development lifecycle.
- Perform additional duties as assigned to advance quality system maturity, analytical readiness, and regulatory compliance.
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Minimum Qualifications
- Bachelor's of Science (or higher) in Chemistry or other related field
- 7 years experience in Pharmaceuticals
- 5 years experience as a QC analyst or Method Development
- Strong experience performing technical review of Analytical Data
- Experience writing & reviewing SOPs, Protocols, Technical Reports 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.
- Competitive compensation
- Health, Dental, and Vision insurance – with generous employer contributions
- 401(k) with employer matching and contribution amounts
- Life insurance and Short- and Long-Term Disability insurance provided by the company
- Generous Paid Time Off and holiday schedules
- Numerous Training and Development opportunities
- and more…
Present in the United States for 60 years, Orano USA is a leading technology and services provider to the U.S. commercial and federal markets.
Orano’s activities in the U.S. include developing uranium enrichment facility in Oak Ridge, TN ; packages and transportation of uranium & nuclear fuel assemblies ; fabricating & installing used nuclear fuel dry storage canisters and casks, conducting pool-to-pad used nuclear fuel transfers ; providing solutions to the National Labs and to the Dept of Energy ; and supplying U.S. nuclear energy utilities with uranium, conversion, and enrichment services.
In the nuclear medicine field, Orano Med is at the forefront of research in nuclear medicine and is developing a new generation of targeted therapies against cancer using the unique properties of lead-212.
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.