Job Description SummaryThe 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 DescriptionKey Responsibilities
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.
Maintain documentation, including batch records,changecontrols, and issue logs for assigned manufacturing sites.
Acknowledge, prioritize, and communicate failure or delay notifications, ensuringsimultaneous awareness among all internal stakeholders and customers.
Compliance & Quality Execution
Conduct checklist-driven readiness reviews for new manufacturing locations, inspections, audits, and partnerreviews.
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).
Process & Continuous Improvement
Required Qualifications
Bachelors degree preferred in Life Sciences, Chemistry, Engineering, or related field. Equivalent experience considered.
Minimum of 3 years of experience in a manufacturing, operations, or quality support role within a regulated environment (pharmaceuticals, biotech, radiopharmaceuticals preferred).
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
For U.S. based positions only, the pay range for this position is $105,600.00-$158,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an. 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
