Description
Orano Med Theranostics 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.
Requirements
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
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.
