Associate Director, Sterile Drug Product Operations Lead

Merck Sharp & Dohme Corp

Rahway, New Jersey, United States
Base: $126,500.00 - $199,100.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
Aseptic drug product manufacturing experience
Cgmp compliance and regulatory standards
Building operations teams from inception
Merck Sharp & Dohme Corp is seeking an Associate Director for Sterile Drug Product Operations to lead the operational strategy and execution of its FLEx Sterile facility in Rahway, NJ. The ideal candidate will have significant experience in aseptic drug product manufacturing and will be responsible for building an operational team, ensuring compliance with GMP standards, and driving continuous improvement

Job Summary

  • This role leads the end-to-end operational strategy for a new sterile drug product facility expanding capacity to double its current output.
  • The successful candidate will build the operations organization from scratch, including recruiting, training, and developing a high-performing team in a GMP environment.
  • Candidates must ensure flawless transition from construction and qualification phases to routine clinical manufacturing with strict adherence to safety and quality metrics.

Matching Summary

Match Score: 85

Merck Sharp & Dohme Corp is seeking an Associate Director for Sterile Drug Product Operations to lead the operational strategy and execution of its FLEx Sterile facility in Rahway, NJ. The ideal candidate will have significant experience in aseptic drug product manufacturing and will be responsible for building an operational team, ensuring compliance with GMP standards, and driving continuous improvement.

Salary

Base: $126,500.00 - $199,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • Aseptic drug product manufacturing experience
  • cGMP compliance and regulatory standards
  • Building operations teams from inception
  • Lean Six Sigma operational excellence
  • Facility start-up and commissioning

Nice-to-have

  • Antibody-drug conjugate (ADC) knowledge
  • Consultative leadership skills
  • Media fill and environmental monitoring expertise
  • Process hazard analysis experience
  • Digital tool implementation

Key Requirements

  • Bachelor's degree plus 8 years experience OR Master's/PhD with reduced years
  • Proven leadership in aseptic drug product manufacturing within GMP settings
  • Experience scaling operations teams and hiring frontline talent

Work Rights

Not specified

Sponsorship: available

Tailored Resume

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