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.
The top priority for the Senior Manager, Production is to provide strategic and operational leadership for all GMP radiopharmaceutical manufacturing activities at ATLab Indianapolis. This role is accountable for ensuring the reliable, compliant, and efficient execution of clinical and commercial production, while developing the long-term capabilities, systems, and culture needed to support site growth.
Key Responsibilities
Leadership & Oversight
- Provide strategic direction, coaching, and performance management for Supervisors, Operators, and technical production staff.
- Drive operational excellence and accountability by setting clear departmental strategies, goals, and KPIs aligned with site and corporate objectives.
- Build and develop organizational capability through succession planning, training programs, and leadership development.
- Serve as a key member of the Site Leadership Team, providing input into site-wide strategy, planning, and resourcing decisions.
Production Operations
- Oversee end-to-end production operations to ensure reliable supply to clinical and commercial customers.
- Direct planning, scheduling, and resource allocation to meet short- and long-term production needs.
- Ensure production readiness, including equipment qualification, material availability, facility readiness, and operator certification.
- Provide oversight and technical leadership during complex operations, atypical events, and high-risk activities.
Quality, Compliance & Safety
- Ensure all operations adhere to cGMP, NRC, ALARA, OSHA, EPA, and state regulations.
- Elevate quality culture by driving excellence in documentation, investigations, change management, and audit readiness.
- Serve as a senior point of escalation for deviations, CAPAs, and risk assessments; ensure timely and effective closure.
- Partner with QA, QC, EHS/ RSO, and Regulatory Affairs to support inspections, license management, and site certifications.
Continuous Improvement
- Lead cross-functional initiatives to improve yield, reduce cycle time, strengthen process capability, and optimize resource utilization.
- Apply Lean, Six Sigma, and Operational Excellence methodologies to eliminate waste and reduce variability.
- Drive introduction and governance of new technologies, systems, and digital tools to enhance operational efficiency.
Other Responsibilities
- Provide leadership and input into site-level strategy, expansion projects, and long-range planning
- Oversee departmental budget planning and financial stewardship.
- Support hiring, onboarding, and organizational plan