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 successful GMP manufacturing and supporting the site’s development and product launches.
The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and sick days.
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, sick days
Skills & Requirements
Must-have
cGMP biological manufacturing
Aseptic manufacturing experience
Equipment Commissioning & Qualification
Process Hazard Analyses participation
Manufacturing batch records creation
Factory and Site Acceptance Testing
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
Cross-functional matrix team collaboration
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 manufacturing
Experience with FAT, SAT, IQ/OQ, and engineering batches
Knowledge of USP1790 and Annex 1 regulatory requirements