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 facility experience
Process hazard analysis and quality risk assessment
Factory acceptance testing and site acceptance testing
** Merck & Co., Inc. is seeking an Associate Director for Technical Operations in Wilmington, DE, to oversee the manufacturing and technology transfer of drug substances, particularly in the context of their new Antibody Drug Conjugate facility. The ideal candidate will possess extensive experience in cGMP environments and a strong technical background in manufacturing processes. **

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 validation, and technology transfer 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 for Technical Operations in Wilmington, DE, to oversee the manufacturing and technology transfer of drug substances, particularly in the context of their new Antibody Drug Conjugate facility. The ideal candidate will possess extensive experience in cGMP environments and a strong technical background in manufacturing processes. **

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
  • Process Hazard Analysis and Quality Risk Assessment
  • Factory Acceptance Testing and Site Acceptance Testing
  • Equipment Commissioning and Qualification IQ/OQ
  • Engineering Batches and Process Performance Qualification

Nice-to-have

  • Start-up experience in large-scale commercial facility
  • Hands-on experience with antibody drug conjugates
  • Six Sigma data-driven root cause analysis
  • FMEA risk-based manufacturing approach
  • Cross-cultural awareness and team leadership

Key Requirements

  • Bachelor's degree in engineering or science
  • Eight or more years in cGMP biological/pharma facility
  • Experience leading FAT, SAT, and Engineering batches
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

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