JOB DESCRIPTION SUMMARY

We are seeking a highly skilled and experienced External Manufacturing Leader to oversee and manage relationships with external manufacturing partners across various sites, specifically those involved in the production of radiotracers. The ideal candidate will have a deep understanding of regulatory frameworks, including 21 CFR 212, and familiarity with radiopharmaceuticals, radiopharmacies, and Board of Pharmacy requirements. This role will focus on ensuring safety, quality, compliance, delivery, speed, and cost across these manufacturing sites while managing the complexities of radiotracer production.

EDUCATION:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Chemistry, or related field; advanced degree (e.g., MBA, Master’s in Supply Chain, or similar) preferred.

EXPERIENCE:

• 8+ years of experience in external manufacturing or operations management within regulated industries such as pharmaceuticals, biotechnology, or radiopharmaceuticals.
• In-depth experience with radiotracers, radiopharmacies, and 21 CFR 212 regulations, including handling and production of radiopharmaceuticals.
• Proven track record in managing relationships with multiple external manufacturing sites, including contract manufacturing organizations (CMOs) specializing in radiotracer production.
• Solid experience in quality management, compliance, and driving continuous improvements in manufacturing operations, particularly in regulated environments.
• Demonstrated success in optimizing production processes for speed and cost while maintaining high regulatory standards.

SKILLS & COMPETENCIES:

• Extensive knowledge of 21 CFR 212, FDA regulations, and GMP as they apply to radiopharmaceuticals and external manufacturing.
• Strong understanding of radiopharmacy operations, Board of Pharmacy requirements, and the handling of radiotracers in accordance with industry standards.
• Strong leadership, interpersonal, and communication skills to effectively manage cross-functional teams and external partners.
• Excellent problem-solving, negotiation, and conflict resolution skills.
• Ability to analyze complex data, identify areas for process improvement, and implement actionable solutions.
• Familiarity with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Proven ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Strong knowledge of SAP, Oracle, or other ERP systems is a plus.

PREFERRED QUALIFICATIONS:

• Experience in managing global manufacturing operations, particularly in the production of radiotracers.
• Prior experience working in a radiopharmaceutical company or a similar regulated manufacturing environment.
• Certification in quality management or project management is a plus.
  For U.S. based positions only, the pay range for this position is $135,200.00-$202,800.00 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.
  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: Yes
  Application Deadline: July 07, 202