Senior Specialist, Drug Product Operations - Wilmington Biotech

Mayoly

Wilmington, Delaware, US
Base: $94,300.00 - $148,500.00; bonus/equity: elig...
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Cgmp biological, vaccine or pharma facility
Aseptic manufacturing experience
Factory acceptance testing (fat)
** Mayoly is seeking a Senior Specialist for Drug Product Operations at their new ADC manufacturing facility in Wilmington, Delaware. This role involves leading GMP manufacturing processes and ensuring operational excellence in a collaborative and innovative environment focused on advancing cancer care. **

Job Summary

  • This role offers you the chance to contribute to the site's development and ensure successful GMP manufacturing.
  • In partnership with site MS&T the Manufacturing Senior Specialist will provide comprehensive manufacturing and technical leadership to the drug product organization.
  • We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Matching Summary

Match Score: 75

** Mayoly is seeking a Senior Specialist for Drug Product Operations at their new ADC manufacturing facility in Wilmington, Delaware. This role involves leading GMP manufacturing processes and ensuring operational excellence in a collaborative and innovative environment focused on advancing cancer care. **

Salary

Base: $94,300.00 - $148,500.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Skills & Requirements

Must-have

  • cGMP biological, vaccine or pharma facility
  • Aseptic manufacturing experience
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Equipment Commissioning & Qualification
  • Manufacturing batch records and SOPs

Nice-to-have

  • Data driven root cause analysis
  • Risk-based approach to manufacturing
  • Lean Six Sigma Continuous Improvement
  • Inclusive environment
  • Right First Time Culture

Key Requirements

  • 5+ years cGMP biological/pharma facility experience
  • Bachelor’s degree in engineering, science or related discipline
  • Start-up experience in large-scale commercial drug product facility
  • Experience with AVI/MVI and creation of library of defects
  • Understanding of USP1790 and Annex 1

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter