Associate External Manufacturing Leader
Remote · United States
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Pay
$106K–$158K/yr
Published in the job listing
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At a glance
- Experience asked
- 3+ years
- Education
- Master's
- Benefits mentioned
- Retirement planGenerous paid leaveRelocation support
Skills mentioned
About the role
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 ensureaccurateandtimelydelivery.
Support root cause investigations for operational deviations, working closely with the Quality and Regulatory teams.
Maintain documentation, including batch records,changecontrols, 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, ensuringsimultaneous awareness among all internal stakeholders and customers.
Compliance & Quality Execution
Monitor site-level compliance with GMP and 21 CFR 212requirements.
Conduct checklist-driven readiness reviews for new manufacturing locations, inspections, audits, and partnerreviews.
Support new customer go-live supply planning and operational supply plans.
Assistin 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 toolsand Power BI dashboards to improve real time external manufacturing visibility
Assistwith onboarding of new regional manufacturing partners, including documentation andlogisticssetup.
Facilitate thecontinuity of supply across various CMO partners when a failure occurs
Process & Continuous Improvement
Identifyareas for operational improvement at the tactical level and propose solutions to drive efficiency.
Help document and implement SOPsand best practices that enhance speed, compliance, or cost-effectiveness.
Participate in lean or Six Sigma-based initiatives to reduce waste and improve process flow.
Assistin the development oflong-termstrategies andexpansion ofmanufacturing 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 communicationand coordination skills across functions and external partners.
Comfortablehandlingproduction 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.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Originally posted on Himalayas