Associate Director, Technical Operations (drug Substance)

leHACK

Wilmington, DE, USA
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
**
8+ years cgmp biological or pharma experience
Lead fat sat iq oq engineering batches
Process hazard analysis and quality risk assessments
** leHACK is seeking an Associate Director of Technical Operations for their new antibody drug conjugate manufacturing facility in Wilmington, DE. The role requires extensive experience in cGMP environments, leadership in manufacturing processes, and a strong technical background in drug substance operations. **

Job Summary

  • The role involves leading the design, commissioning, and operation of a cutting-edge Antibody Drug Conjugate manufacturing facility in Wilmington, Delaware.
  • Candidates must possess eight or more years of experience in a cGMP biological, vaccine, or pharma facility to ensure successful technology transfer and process validation.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligible for this hybrid position.

Matching Summary

Match Score: 75

** leHACK is seeking an Associate Director of Technical Operations for their new antibody drug conjugate manufacturing facility in Wilmington, DE. The role requires extensive experience in cGMP environments, leadership in manufacturing processes, and a strong technical background in drug substance operations. **

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
  • Lead FAT SAT IQ OQ engineering batches
  • Process Hazard Analysis and Quality Risk Assessments
  • Technical leadership in chromatography and TFF
  • Experience with Antibody Drug Conjugates manufacturing

Nice-to-have

  • Start-up experience in large-scale commercial facility
  • Six Sigma data-driven root cause analysis
  • FMEA risk-based manufacturing approach
  • Cross-cultural awareness and team collaboration
  • Experience with RFT implementation execution

Key Requirements

  • Bachelor's degree in engineering or science
  • Minimum 8 years cGMP pharmaceutical experience
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

Cover Letter