Quality Control Supervisor

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches. Position Summary This is a working supervisor role. The individual is expected to learn, remain proficient in, and provide hands‑on support for all assigned test methods, laboratory processes, and documentation practices. The Supervisor will set daily priorities, maintain a strong laboratory presence, and make timely operational and technical decisions. The Supervisor will serve as a technical subject‑matter expert and people leader. Responsibilities include analyst training, performance management, conflict resolution, laboratory investigations, and cross‑functional communication. Success requires sound scientific judgment, strong technical writing and verbal communication, and calm decision‑making under time‑sensitive conditions. Setup & Development Phase Learn, perform, and maintain proficiency in all analytical test methods, laboratory processes, and controlled documentation practices within the assigned area. Support analytical method development, optimization, qualification, validation, transfer, and lifecycle activities. Establish training plans, qualification requirements, testing workflows, and clear expectations for compliant laboratory execution. Support laboratory commissioning, instrument qualification, method readiness, staffing readiness, and analyst training. Author and review protocols, reports, standard operating procedures, specifications, investigations, and other technical documents. Provide scientific and operational input during process development, technology transfer, validation, and regulatory submission activities. Production Phase Top Priority: Execute and supervise QC testing for batch release within hours of production Routine Functions - QC Direct daily QC Chemistry laboratory operations, assign work, balance staffing, and ensure testing priorities are clearly understood. Maintain hands‑on capability and perform or directly support routine test methods when needed to protect testing timelines and product release. Serve as the primary technical subject‑matter expert for analytical methods, laboratory investigations, and complex technical issues. Make timely laboratory decisions during testing and release, escalating significant quality, safety, or compliance risks appropriately. Coordinate testing priorities with Manufacturing, Quality Assurance, Supply Chain, and other functions to meet production schedules. Train, coach, and evaluate laboratory personnel; provide clear feedback, reinforce accountability, and resolve personnel conflicts promptly and fairly. Maintain a visible leadership presence in the laboratory during critical testing, troubleshooting, and release operations. Review analytical data, laboratory records, calculations, and results for accuracy, completeness, scientific validity, and compliance. Lead laboratory investigations and corrective actions, and support inspections, audits, deviations, change controls, and CAPA activities. Evaluate method performance, laboratory trends, deviations, recurring issues, and workload data to identify improvement opportunities. Lead root‑cause analysis and ensure corrective actions address technical, procedural, and organizational causes. Improve laboratory workflows, training systems, documentation quality, and inspection readiness while maintaining cGMP compliance. Promote knowledge sharing, technical development, effective communication, and cross‑functional collaboration. Location: On-site 100% Direct daily QC Chemistry laboratory operations, assign work, balance staffing, and ensure testing priorities are clearly understood. Maintain hands‑on capability and perform or directly support routine test methods when needed to protect testing timelines and product release. Serve as the primary technical subject‑matter expert for analytical methods, laboratory investigations, and complex technical issues. Make timely laboratory decisions during testing and release, escalating significant quality, safety, or compliance risks appropriately. Coordinate testing priorities with Manufacturing, Quality Assurance, Supply Chain, and other functions to meet production schedules. Train, coach, and evaluate laboratory personnel; provide clear feedback, reinforce accountability, and resolve personnel conflicts promptly and fairly. Maintain a visible leadership presence in the laboratory during critical testing, troubleshooting, and release operations. Review analytical data, laboratory records, calculations, and results for accuracy, completeness, scientific validity, and compliance. Lead laboratory investigations and corrective actions, and support inspections, audits, deviations, change controls, and CAPA activities. Continuous Improvement Evaluate method performance, laboratory trends, deviations, recurring issues, and workload data to identify improvement opportunities. Lead root‑cause analysis and ensure corrective actions address technical, procedural, and organizational causes. Improve laboratory workflows, training systems, documentation quality, and inspection readiness while maintaining cGMP compliance. Promote knowledge sharing, technical development, effective communication, and cross‑functional collaboration. Location: On-site 100% This position may receive other responsibilities as needed. Requirements Qualifications Education Bachelor's degree in chemistry, analytical chemistry, pharmaceutical sciences, radiochemistry, or a related scientific discipline is required. A Master's degree is preferred. Experience At least 5 years of experience in pharmaceutical quality control, analytical development, or a related GMP laboratory function. At least 1 year of experience as a laboratory supervisor, team lead, or technical lead with responsibility for directing personnel and work. Direct experience supporting radiopharmaceutical drug testing is strongly preferred. Strong knowledge of analytical method execution, qualification, validation, transfer, troubleshooting, and lifecycle management. Experience in a GMP-regulated environment supporting clinical or commercial manufacturing. Hands‑on experience with techniques such as HPLC, GC, gamma spectroscopy, radio‑TLC, dose calibrators, and related instrumentation. Demonstrated technical writing, verbal communication, decision‑making, coaching, and personnel conflict‑resolution skills. Skills Strong laboratory presence, safety awareness, and hands‑on technical leadership Technical subject‑matter expertise, scientific troubleshooting, and data review Sound decision‑making under time‑critical conditions Clear technical writing and effective verbal communication Coaching, performance feedback, accountability, and personnel conflict resolution Organization, prioritization, attention to detail, and urgency while maintaining cGMP standards Other Travel Lift 50 lbs. 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 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. #J-18808-Ljbffr