Associate Director, Process Engineering - Oral Solid Dosage, Clinical Manufacturing (onsite)

Merck & Co., Inc.

Rahway, New Jersey, USA
$142,400.00 - $224,100.00; bonus/equity: eligible ...
3 days onsite, 1 day remote (hybrid)
Oral solid dosage manufacturing
Gmp documentation review and approval
Process robustness assessments
Merck & Co., Inc. is seeking an Associate Director for Process Engineering in their Rahway, New Jersey facility, responsible for ensuring the quality and efficiency of clinical manufacturing for oral solid dosage forms. The ideal candidate will have extensive experience in GMP manufacturing and leadership, particularly in small-molecule drug product processing

Job Summary

  • Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
  • Mentor a team of 2-5 process engineers by technical coaching and developing for success through feedback and development guidance.
  • Own impactful and complex technical projects that leverage Design of Experiments and Quality by Design (QbD) principles to increase process understanding, address gaps or accelerate scale-up to commercial manufacturing.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Director for Process Engineering in their Rahway, New Jersey facility, responsible for ensuring the quality and efficiency of clinical manufacturing for oral solid dosage forms. The ideal candidate will have extensive experience in GMP manufacturing and leadership, particularly in small-molecule drug product processing.

Salary

$142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Oral Solid Dosage manufacturing
  • GMP documentation review and approval
  • Process robustness assessments
  • Root cause analysis
  • Deviation management
  • cGMP, FDA, EMA regulatory requirements

Nice-to-have

  • Subject matter expert in drug delivery
  • Experience in Formulation and Analytical Sciences
  • Audit experience
  • Clinical Supply Chain Operations knowledge
  • Spray dried intermediates and/or hot melt extrusion experience

Key Requirements

  • 10+ years relevant experience with BS
  • 8+ years relevant experience with MS
  • 4+ years relevant experience with PhD
  • Experience leading GMP manufacturing facilities
  • Experience authoring, reviewing, and approving GMP documentation
  • Experience with small-molecule GMP drug product processing

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter