Quality Control Supervisor

Orano; Brownsburg (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Orano Med in Brownsburg, Indiana seeks a working supervisor to lead QC chemistry operations, train analysts, and ensure compliant laboratory practices in a cGMP environment.

You will set priorities, supervise testing for batch release, investigate deviations, and drive continuous improvement across analytical methods and cross-functional teams.

This role combines hands-on testing with leadership, documentation, and timely decision-making under time-sensitive conditions.

Qualifications

• Bachelors degree in a scientific field required or equivalent experience.
• Experience leading QC or analytical labs in a regulated environment.
• Strong writing and communication skills; able to document investigations.

Responsibilities

• Lead daily QC Chemistry laboratory operations and oversee batch release testing.
• Train, coach, and evaluate laboratory personnel; enforce cGMP compliance.
• Review data and investigations; lead root-cause analyses and CAPA activities.
• Coordinate priorities with Manufacturing, QA, and Supply Chain to meet schedules.

Skills

Laboratory supervision

QC testing

Analytical methods

Technical writing

Cross-functional communication

Education

Bachelor’s degree in a relevant scientific field

Tools

HPLC

Analytical instruments

Job description

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.

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%

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.

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.