Senior Specialist, Drug Product Operations - Wilmington Biotech

Newyorkbioconnect

Wilmington, DE, US
Base: $94,300.00 - $148,500.00; bonus/equity: elig...
Hybrid
Cgmp biological manufacturing
Aseptic manufacturing experience
Process hazard analysis
Join a cutting-edge Antibody Drug Conjugate manufacturing facility in Wilmington, Delaware, focused on transforming cancer care through innovation and collaboration

Job Summary

  • Join a cutting-edge Antibody Drug Conjugate manufacturing facility in Wilmington, Delaware, focused on transforming cancer care through innovation and collaboration.
  • The Manufacturing Senior Specialist will play a pivotal role in ensuring smooth GMP manufacturing operations and supporting successful product launches.
  • The company offers a comprehensive benefits package, a hybrid work model, and fosters a culture of excellence, inclusion, and impact.

Matching Summary

Join a cutting-edge Antibody Drug Conjugate manufacturing facility in Wilmington, Delaware, focused on transforming cancer care through innovation and collaboration.

Salary

Base: $94,300.00 - $148,500.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation

Skills & Requirements

Must-have

  • cGMP biological manufacturing
  • Aseptic manufacturing experience
  • Process hazard analysis
  • Equipment commissioning and qualification
  • Manufacturing batch record creation
  • Process performance qualification
  • Risk-based manufacturing approach

Nice-to-have

  • Start-up experience in commercial drug product facility
  • Data-driven root cause analysis
  • Lean Six Sigma continuous improvement
  • Technical writing skills
  • Collaboration in matrix teams
  • Safety and quality culture promotion
  • Inclusive work environment

Key Requirements

  • Bachelor’s degree in engineering or science
  • 5+ years cGMP biological or pharma facility experience
  • Prior aseptic manufacturing experience
  • Experience with FAT, SAT, IQ/OQ, and engineering batches
  • Knowledge of USP1790 and regulatory requirements
  • Ability to support CQV activities
  • Experience with Six Sigma or similar methodologies

Work Rights

US and Puerto Rico Residents Only

Sponsorship: available

Tailored Resume

Cover Letter