Senior Specialist, Drug Product Operations - Wilmington Biotech

leHACK

Wilmington, Delaware, US
Base: $94,300.00 - $148,500.00; bonus/equity: annu...
Hybrid
Cgmp biological/vaccine/pharma facility
Aseptic manufacturing experience
Engineering design firm engagement
We are launching a cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware, to transform cancer care through innovation and purpose-driven science

Job Summary

  • We are launching a cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware, to transform cancer care through innovation and purpose-driven science.
  • This role offers the chance to contribute to site development and ensure successful GMP manufacturing, providing comprehensive manufacturing and technical leadership to the drug product organization.
  • The company offers a comprehensive package of benefits including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and compassionate and sick days.

Matching Summary

We are launching a cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware, to transform cancer care through innovation and purpose-driven science.

Salary

Base: $94,300.00 - $148,500.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • cGMP biological/vaccine/pharma facility
  • Aseptic manufacturing experience
  • Engineering design firm engagement
  • Process Hazard Analyses
  • Quality Risk Assessments
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)

Nice-to-have

  • Safety First, Quality Always mindset
  • Right First Time Culture
  • Data driven approach
  • Risk-based approach to manufacturing
  • Adapt to changing priorities

Key Requirements

  • Five or more (5+) years cGMP 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
  • Experience with CQV activities
  • Experience in data driven root cause analysis
  • Experience in risk-based approach through FMEA

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter