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 its new Antibody Drug Conjugate manufacturing facility in Wilmington, DE. The role involves overseeing manufacturing processes, leading technical teams, and ensuring compliance within a collaborative environment focused on innovative cancer therapies

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, driving process hazard analyses, and overseeing equipment qualification from design through operation.
  • Candidates will receive a competitive salary range of $142,400.00 to $224,100.00 along with comprehensive benefits including medical, dental, vision, and 401(k).

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 overseeing manufacturing processes, leading technical teams, and ensuring compliance within a collaborative environment focused on innovative cancer therapies.

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
  • Manage process hazard and quality risk assessments
  • Oversee equipment commissioning and validation deliverables

Nice-to-have

  • Start-up experience in large-scale commercial facility
  • Hands-on experience with antibody drug conjugates
  • Expertise in chromatography and TFF operations
  • Six Sigma data driven root cause analysis
  • Risk-based manufacturing using FMEA tools

Key Requirements

  • Bachelor's degree in engineering or science
  • Eight or more years in cGMP facility
  • Experience with shakedown and PPQ batches
  • No visa sponsorship available

Work Rights

Not specified

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