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

539

Rahway, New Jersey, USA
Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid (3 days onsite, 1 day remote)
Gmp manufacturing facilities
Oral solid dosage forms
Process robustness assessments
The Associate Director, Process Engineering position at a clinical manufacturing facility in Rahway, New Jersey, requires extensive experience in GMP manufacturing and process engineering for oral solid dosage forms. The role focuses on leading clinical supply manufacturing, mentoring engineers, and ensuring compliance with regulatory standards while fostering a culture of collaboration and innovation

Job Summary

  • The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products, leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating.
  • This person will lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
  • The salary range for this role is $142,400.00 - $224,100.00, with eligibility for annual bonus and long-term incentive, and a comprehensive package of benefits.

Matching Summary

Match Score: 85

The Associate Director, Process Engineering position at a clinical manufacturing facility in Rahway, New Jersey, requires extensive experience in GMP manufacturing and process engineering for oral solid dosage forms. The role focuses on leading clinical supply manufacturing, mentoring engineers, and ensuring compliance with regulatory standards while fostering a culture of collaboration and innovation.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: comprehensive package of benefits

Skills & Requirements

Must-have

  • GMP manufacturing facilities
  • Oral solid dosage forms
  • Process robustness assessments
  • Root cause analysis
  • Deviation management
  • First-principles understanding

Nice-to-have

  • Foster culture of collaboration
  • Learning and innovation
  • Subject matter expert
  • Technical transfer of early-phase drug product
  • Hands-on optimization of existing technologies

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
  • Strong knowledge of cGMP, FDA, EMA, and international regulatory requirements

Work Rights

Not specified

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