External Manufacturing Leader

GEHC

Remote, US
Base: $140,000.00-$210,000.00 annual; bonus/equity...
External manufacturing partner management
Radiotracer production oversight
21 cfr 212 compliance
Oversee and manage relationships with external manufacturing partners, specifically those involved in radiotracer production, ensuring safety, quality, compliance, delivery, speed, and cost

Job Summary

  • Oversee and manage relationships with external manufacturing partners, specifically those involved in radiotracer production, ensuring safety, quality, compliance, delivery, speed, and cost.
  • Ensure all external manufacturing operations adhere to safety regulations, comply with 21 CFR 212, FDA regulations, and Board of Pharmacy requirements for radiopharmaceuticals.
  • Optimize manufacturing processes for speed-to-market and cost-effectiveness, while managing risks and collaborating with internal teams and senior management.

Matching Summary

Oversee and manage relationships with external manufacturing partners, specifically those involved in radiotracer production, ensuring safety, quality, compliance, delivery, speed, and cost.

Salary

Base: $140,000.00-$210,000.00 Annual; Bonus/Equity: Performance based incentive compensation; Benefits: Medical, dental, vision, PTO, 401(k), life, disability, accident insurance, tuition reimbursement

Skills & Requirements

Must-have

  • External manufacturing partner management
  • Radiotracer production oversight
  • 21 CFR 212 compliance
  • Regulatory framework adherence
  • Quality and compliance assurance

Nice-to-have

  • Lean Manufacturing and Six Sigma
  • Global manufacturing operations experience
  • ERP system familiarity

Key Requirements

  • 8+ years of experience
  • Bachelor's degree required
  • Experience in regulated industries
  • Proven track record managing CMOs
  • Experience with quality management and compliance

Work Rights

Legally authorized to work in the United States

Tailored Resume

Cover Letter