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.