Associate Director, Technical Operations (drug Substance)

Merck & Co., Inc.

Wilmington, DE, USA
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
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8+ years cgmp biological or pharma experience
Lead engineering design firms for drug substance
Execute factory acceptance testing (fat) and site acceptance testing (sat)
** Merck & Co., Inc. is seeking an Associate Director of Technical Operations for its new Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, DE. The role involves overseeing various aspects of manufacturing and technology transfer while leading efforts to ensure compliance with safety and quality standards. **

Job Summary

  • This role offers the opportunity to lead the build, commissioning, and qualification of a cutting-edge Antibody Drug Conjugate manufacturing facility in Wilmington, Delaware.
  • The successful candidate will provide comprehensive technical leadership on manufacturing processes including conjugation, chromatography, and filling while ensuring compliance with cGMP standards.
  • 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

** Merck & Co., Inc. is seeking an Associate Director of Technical Operations for its new Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, DE. The role involves overseeing various aspects of manufacturing and technology transfer while leading efforts to ensure compliance with safety and quality standards. **

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 engineering design firms for drug substance
  • Execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
  • Manage Process Hazard Analyses and Quality Risk Assessments
  • Oversee Equipment Commissioning & Qualification (IQ/OQ)
  • Provide technical leadership in chromatography and TFF

Nice-to-have

  • Start-up experience in large-scale commercial facilities
  • Hands-on experience with antibody drug conjugates
  • Six Sigma data-driven root cause analysis
  • Risk-based manufacturing using FMEA tools
  • Cross-cultural awareness and team collaboration

Key Requirements

  • Bachelor's degree in engineering or science
  • Eight or more years in cGMP biological/pharma facility
  • Experience with Engineering Batches and PPQ runs
  • No visa sponsorship available

Work Rights

Not specified

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