Associate External Manufacturing Leader

Job Title: Associate External Manufacturing Leader

Job Location: Remote

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

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.