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

Merck Sharp & Dohme Corp

Rahway, New Jersey, US
$142,400.00 - $224,100.00; bonus + long-term incen...
Hybrid
Gmp manufacturing operations
Oral solid dosage processing
Process robustness assessments
Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products

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

Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.

Salary

$142,400.00 - $224,100.00; Bonus and long-term incentive eligible; Comprehensive benefits package

Skills & Requirements

Must-have

  • GMP manufacturing operations
  • Oral Solid Dosage processing
  • Process robustness assessments
  • Root cause analysis
  • Deviation management
  • cGMP, FDA, EMA regulatory requirements

Nice-to-have

  • Subject matter expert in drug delivery
  • Cross-functional team collaboration
  • Culture of learning and innovation
  • Hands-on technology optimization

Key Requirements

  • Minimum 10 years relevant experience with BS
  • Minimum 8 years relevant experience with MS
  • Minimum 4 years relevant experience with PhD
  • Experience authoring, reviewing, and approving GMP documentation
  • Experience supporting or leading GMP manufacturing facilities

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter