Associate Director, Technical Operations (drug Substance)

Merck & Co., Inc.

Wilmington, DE, USA
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
8+ years cgmp biological facility experience
Antibody drug conjugate (adc) manufacturing
Process hazard analysis and quality risk assessments
Merck & Co., Inc. is seeking an Associate Director of Technical Operations for its new Antibody Drug Conjugate manufacturing facility in Wilmington, DE. The role involves leading various aspects of manufacturing and technical operations, ensuring excellence, safety, and innovation in cancer treatment

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 engineering design, process hazard analyses, and equipment qualification activities from design through operation.
  • 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: 85

Merck & Co., Inc. is seeking an Associate Director of Technical Operations for its new Antibody Drug Conjugate manufacturing facility in Wilmington, DE. The role involves leading various aspects of manufacturing and technical operations, ensuring excellence, safety, and innovation 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 facility experience
  • Antibody Drug Conjugate (ADC) manufacturing
  • Process Hazard Analysis and Quality Risk Assessments
  • Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
  • Equipment Commissioning and Qualification (IQ/OQ)
  • Technical leadership in chromatography and TFF
  • Engineering batch and PPQ execution

Nice-to-have

  • Start-up experience in commercial drug substance facility
  • Six Sigma continuous improvement initiatives
  • Risk-based manufacturing using FMEA tools
  • Data-driven root cause analysis skills
  • Cross-cultural awareness and teamwork

Key Requirements

  • Bachelor's degree in engineering or science
  • Eight or more years in cGMP biological/pharma facility
  • Experience with shakedown and engineering batches
  • Strong technical writing and communication skills

Work Rights

Not specified

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