Quality Scientist

Orano Med, LLC.; Plano (TX); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401(k) with employer match

Life insurance

Short- and Long-Term Disability

Paid Time Off

Training and Development opportunities

Job summary

Orano Med LLC in Plano, TX, is seeking a Quality Scientist to ensure the integrity and regulatory compliance of analytical methods for drug product testing from development through Phase 2 manufacturing. You will lead investigations, CAPAs, method qualification, validation, and transfer in line with FDA/EMA guidelines.

The role requires strong GMP knowledge, meticulous data translation, and collaboration with QC, Analytical Development, Manufacturing, and QA teams to deliver robust data and

Qualifications

• Bachelor's of Science (or higher) in Chemistry or related field.
• 7+ years experience in Pharmaceuticals.
• 5+ years experience as a QC analyst or Method Development.

Responsibilities

• Perform technical review of QC analytical data and reports to verify accuracy and data integrity.
• Lead analytical method qualification, validation, and transfer activities per ICH Q2/Q14, FDA/EMA guidelines.
• Drive improvement of qualification/validation programs through data trending and method performance monitoring.
• Investigate deviations, OOS/OOT results, and nonconformances with robust root cause analysis and CAPA.
• Provide technical review and approval of method transfer packages and validation documents.
• Assess manufacturing processes and R&D recommendations to identify risks and support optimization.
• Execute complex quality and analytical tasks to deliver high-quality data, methods, and processes.
• Perform additional duties to advance quality system maturity and regulatory compliance.

Skills

Analytical method review

GMP compliance

Regulatory knowledge

Data interpretation

Education

Bachelor's degree in Chemistry or related field

Job description

Job Overview

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is 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 an opening for a 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.

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

Preferred Skills & Competencies

• 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.

Benefits

• 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

Employment Eligibility & Equal Opportunity Statement

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.