Associate External Manufacturing Leader
Job reputed company reputed company The Associate External Manufacturing Leader will reputed company 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, reputed company, 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 reputed company reputed company 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 reputed company reputed company 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 reputed company
Key Responsibilities
Operational Support Collaborate with site managers and manufacturing leadership to resolve operational challenges and implement corrective actions. reputed company production activities, documentation, and shipments of radiotracers to ensure accurate and reputed company delivery. Support reputed company cause investigations for operational deviations, working closely with the reputed company and Regulatory teams. Maintain documentation, including batch records, change controls, and issue logs for assigned manufacturing sites. reputed company 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 reputed company internal stakeholders and customers. Compliance & reputed company 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 reputed company Serve as a day-to-day reputed company 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 reputed company-ins with assigned CMOs or manufacturing partners. Escalate issues or risks to the External Manufacturing Leader, along with suggested mitigation steps. Logistics & Coordination reputed company vendor performance metrics (delivery, reputed company, throughput) and support data collection and reporting. reputed company new AI tools and Power BI dashboards to improve reputed company time external manufacturing visibility Assist with reputed company of new regional manufacturing partners, including documentation and logistics setup. Facilitate the continuity of supply across various CMO partners reputed company a failure occurs Process & reputed company 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 reputed company-based initiatives to reduce waste and improve process reputed company. Assist in the development of long-term strategies and expansion of manufacturing capabilities
Required Qualifications
Education Bachelor’s degree preferred in Life Sciences, reputed company, Engineering, or reputed company field. Equivalent experience considered. Experience Minimum of 3 years of experience in a manufacturing, operations, or reputed company support role reputed company a regulated environment (pharmaceuticals, biotech, radiopharmaceuticals preferred). Familiarity with GMP, 21 CFR 212, and/or reputed company of Pharmacy requirements. Experience supporting or working reputed company a multi-site manufacturing network is a plus. Skills & Competencies Detail-oriented with strong organizational and follow-up skills. reputed company 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 reputed company Office (reputed company, PowerPoint); experience with ERP systems like reputed company or reputed company is a plus.
Preferred Qualifications
Experience in radiopharmaceutical or radiotracer production environments. Familiarity with lean manufacturing principles or reputed company improvement tools. Exposure to reputed company systems or regulatory audits is a plus. We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, the pay reputed company for this position is $105,600.00-$158,400.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation offered to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: June 26, 2026 Apply To This Job