Associate Director, Technical Operations (drug Substance)

39med

Wilmington, DE, US
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
**
8+ years cgmp biological or pharma experience
Process hazard analysis and quality risk assessment
Factory acceptance testing (fat) and site acceptance testing (sat)
** 39med is seeking an Associate Director of Technical Operations for their new Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, DE. The role involves overseeing manufacturing processes, change management, and technology transfer, with a focus on innovation and collaboration in cancer treatment. **

Job Summary

  • This role offers the opportunity to lead the design, build, and operation of a cutting-edge Antibody Drug Conjugate manufacturing facility in Wilmington, Delaware.
  • The successful candidate will provide comprehensive technical leadership on process hazard analyses, equipment qualification, and technology transfer activities.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 75

** 39med is seeking an Associate Director of Technical Operations for their new Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, DE. The role involves overseeing manufacturing processes, change management, and technology transfer, with a focus on innovation and collaboration in cancer treatment. **

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 8+ years cGMP biological or pharma experience
  • Process Hazard Analysis and Quality Risk Assessment
  • Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
  • Equipment Commissioning and Qualification (IQ/OQ)
  • Technical leadership in conjugation and chromatography

Nice-to-have

  • Start-up experience in commercial drug substance facility
  • Hands-on experience with Antibody Drug Conjugates (ADC)
  • Six Sigma root cause analysis expertise
  • Risk-based manufacturing using FMEA tools
  • Cross-cultural awareness and team collaboration

Key Requirements

  • Bachelor's degree in engineering or science
  • Minimum 8 years in cGMP biological/vaccine/pharma facility
  • Experience with Engineering Batches and Process Performance Qualifications
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

Cover Letter