Head of Quality and Analytical Development, Cell Therapy

Added
9 minutes ago
Type
Full time
Salary
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Related skills

gmp flow cytometry elisa cell therapy qpcr

πŸ“‹ Description

  • Lead Retro's Quality & Analytical Development team, setting priorities, coaching and developing
  • Be accountable for the phase-appropriate QMS and independent Quality oversight supporting internal
  • Partner with Program teams across R&D, Process Development, and Manufacturing, as well as
  • Guide analytical strategy and the full method lifecycle across our cell-therapy programs, from
  • Provide technical leadership across cell-therapy methods including flow cytometry, potency and
  • Oversee Quality review of GMP records, deviations, CAPAs, change controls, qualification/validation

🎯 Requirements

  • Have 8+ years of relevant experience, with deep cell-therapy experience and substantial
  • Have taken cell-therapy programs through GMP manufacturing and clinical development.
  • Have meaningful experience building and operating a phase-appropriate GMP Quality system.
  • Have personally taken cell-therapy analytical methods through the full lifecycle, from development
  • Bring deep hands-on expertise in one or more cell-therapy analytical areas, such as flow cytometry
  • Have experience with batch review, disposition, or release decisions in a GMP environment.

🎁 Benefits

  • Medical, dental, and vision insurance for you and your family
  • 401(k) plan with 4% matching
  • Flexible time off and 10 company holidays per year
  • Paid parental and medical leave
  • Annual learning & development stipend
  • Monthly Longevity stipend
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