Associate External Manufacturing Leader

Job Description Summary

The Associate External Manufacturing Leader will provide tactical support across the radiotracer production network. Reporting to the External Manufacturing Leader (EML), this role involves executing and monitoring daily operations across the External Manufacturing network as assigned by the EML, ensuring compliance, quality, and on-time delivery from external manufacturing partners, while contributing to the strategic goals and initiatives of the External Manufacturing Organization.

This role requires strong organizational skills, comfort working with regulated processes, and a collaborative mindset to support external sites and internal cross-functional teams. Ideal candidates will have experience in pharmaceutical or radiopharmaceutical manufacturing and working knowledge of relevant regulations (e.g., 21 CFR 212, GMP). This role requires strong organizational skills, comfort working with regulated processes, and a collaborative mindset to support external sites and internal cross-functional teams. Ideal candidates will have experience in pharmaceutical or radiopharmaceutical manufacturing and working knowledge of relevant regulations (e.g., 21 CFR 212, GMP).

Job Description

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.

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