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 on-site, 1 day remote)
8+ years cgmp biological or pharma experience
Lead engineering design firms for drug substance
Execute fat sat iq oq qualification activities
Merck & Co., Inc. is seeking an Associate Director of Technical Operations for their new Antibody Drug Conjugate manufacturing facility in Wilmington, DE. The role involves overseeing manufacturing processes, providing technical leadership, and ensuring compliance with cGMP standards, all while contributing to innovative cancer treatments

Job Summary

  • Join the launch of a cutting-edge Antibody Drug Conjugate manufacturing facility in Wilmington, Delaware to transform cancer care.
  • The role involves leading engineering design, process hazard analyses, and equipment qualification from design through commercial operation.
  • Candidates will receive a comprehensive benefits package including medical, dental, vision, 401(k), and an annual bonus eligibility.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Director of Technical Operations for their new Antibody Drug Conjugate manufacturing facility in Wilmington, DE. The role involves overseeing manufacturing processes, providing technical leadership, and ensuring compliance with cGMP standards, all while contributing to innovative cancer treatments.

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 FAT SAT IQ OQ qualification activities
  • Oversee process performance qualifications and commercial manufacturing
  • Manage change control and deviation management systems

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 skills
  • Risk-based manufacturing approach 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 shakedown batches and PPQ runs
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

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