Key Responsibilities 

Operational Support 

• Collaborate with site managers and manufacturing leadership to resolve operational challenges and implement corrective actions. Track production activities, documentation, and shipments of radiotracers to ensure accurate and timely delivery. 

• Support root cause investigations for operational deviations, working closely with the Quality and Regulatory teams. 

• Maintain documentation, including batch records, change controls, and issue logs for assigned manufacturing sites. 

• Provide regular performance reports to the External Manufacturing Leader and senior leadership. 

• Support the External Manufacturing Leader in leading regular business reviews with external partners 

• Acknowledge, prioritize, and communicate failure or delay notifications, ensuring simultaneous awareness among all internal stakeholders and customers. 

Compliance & Quality Execution 

• Monitor site-level compliance with GMP and 21 CFR 212 requirements. 

• Conduct checklist-driven readiness reviews for new manufacturing locations, inspections, audits, and partner reviews. 

• Support new customer go-live supply planning and operational supply plans.  

• Assist in the review and tracking of CAPAs, deviations, and SOP updates as directed by the External Manufacturing Leader. 

• Partner and Site Interface 

• Serve as a day-to-day liaison between regional manufacturing partners and internal teams (e.g., External Manufacturing, Materials Management, QA, MSAT, R&D, Service, and Logistics). 

• Attend and document regular calls or check-ins with assigned CMOs or manufacturing partners. 

• Escalate issues or risks to the External Manufacturing Leader, along with suggested mitigation steps. 

Logistics & Coordination 

• Track vendor performance metrics (delivery, quality, throughput) and support data collection and reporting. 

• Integrate new AI tools and Power BI dashboards to improve real time external manufacturing visibility  

• Assist with onboarding of new regional manufacturing partners, including documentation and logistics setup. 

• Facilitate the continuity of supply across various CMO partners when a failure occurs 

Process & Continuous Improvement 

• Identify areas for operational improvement at the tactical level and propose solutions to drive efficiency. 

• Help document and implement SOPs and best practices that enhance speed, compliance, or cost-effectiveness. 

• Participate in lean or Six Sigma-based initiatives to reduce waste and improve process flow. 

• Assist in the development of long-term strategies and expansion of manufacturing capabilities  

Required Qualifications 

Education 

• Bachelor’s degree preferred in Life Sciences, Chemistry, Engineering, or related field. Equivalent experience considered. 

Experience 

• Minimum of 3 years of experience in a manufacturing, operations, or quality support role within a regulated environment (pharmaceuticals, biotech, radiopharmaceuticals preferred). 

• Familiarity with GMP, 21 CFR 212, and/or Board of Pharmacy requirements. 

• Experience supporting or working within a multi-site manufacturing network is a plus. 

Skills & Competencies 

• Detail-oriented with strong organizational and follow-up skills. 

• Able to work independently while keeping leadership informed of key issues. 

• Strong communication and coordination skills across functions and external partners. 

• Comfortable handling production data, SOPs, and documentation. 

• Proficient in Microsoft Office (Excel, PowerPoint); experience with ERP systems like SAP or Oracle is a plus. 

Preferred Qualifications 

• Experience in radiopharmaceutical or radiotracer production environments. 

• Familiarity with lean manufacturing principles or continuous improvement tools. 

• Exposure to quality systems or regulatory audits is a plus.