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

539

Rahway, New Jersey, United States
$142,400.00 - $224,100.00; bonus + long-term incen...
Hybrid
Oral solid dosage manufacturing
Gmp documentation review and approval
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

  • Oral Solid Dosage manufacturing
  • GMP documentation review and approval
  • Process robustness assessments
  • Root cause analysis
  • cGMP, FDA, EMA regulatory knowledge
  • Small molecule drug product processing

Nice-to-have

  • Subject matter expert in drug delivery
  • Cross-functional team collaboration
  • Foster culture of collaboration
  • Drive innovation and learning
  • Evaluate new technologies

Key Requirements

  • Bachelor of Science degree with 10 years experience
  • Master’s degree with 8 years experience
  • PhD degree with 4 years experience
  • Experience supporting GMP manufacturing facilities
  • Experience authoring GMP documentation
  • Experience with change controls and quality investigations

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter