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 role offers the opportunity to contribute to site development and ensure successful GMP manufacturing with a focus on drug product operations.
The company provides a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, and vacation, supporting a hybrid work model for office-based roles.
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 or pharma facility experience
Aseptic manufacturing expertise
Equipment commissioning and qualification
Process Hazard Analyses participation
Technical document creation and revision
Execution of engineering and commercial batches
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
Cross-functional matrix team collaboration
Communication and technical writing skills
Safety First, Quality Always mindset
Inclusion and Right First Time culture
Key Requirements
Bachelor’s degree in engineering or science
5+ years cGMP biological or pharma facility experience
Prior aseptic manufacturing experience
Start-up experience in large-scale commercial drug product facility
Experience with FAT, SAT, IQ/OQ, PPQ runs
Knowledge of USP1790 and Annex 1 regulatory requirements