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

Drugdiscovery

Rahway, New Jersey, US
$142,400.00 - $224,100.00; bonus/equity: eligible ...
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Oral solid dosage manufacturing
Gmp documentation review and approval
Process robustness assessments
** The Associate Director of Process Engineering at Drugdiscovery is responsible for leading clinical supply manufacturing in an oral solid dosage facility, ensuring high-quality production and compliance with GMP standards. The role requires significant experience in drug product processing and includes mentoring a team of engineers, overseeing technical projects, and engaging with partners for commercialization. **

Job Summary

  • The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products leveraging pharmaceutical unit operations.
  • Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
  • We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits, retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Matching Summary

Match Score: 75

** The Associate Director of Process Engineering at Drugdiscovery is responsible for leading clinical supply manufacturing in an oral solid dosage facility, ensuring high-quality production and compliance with GMP standards. The role requires significant experience in drug product processing and includes mentoring a team of engineers, overseeing technical projects, and engaging with partners for commercialization. **

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
  • Continuous improvement efforts
  • Scale-up to commercial manufacturing

Nice-to-have

  • Foster culture of collaboration
  • Learning and innovation
  • Independent problem-solving
  • Diverse, cross-functional team

Key Requirements

  • Bachelor of Science degree with 10 years relevant experience
  • Master’s degree with 8 years relevant experience
  • PhD degree with 4 years relevant experience
  • Experience authoring, reviewing and approving batch records
  • Extensive knowledge in small-molecule GMP drug product processing
  • Strong knowledge of cGMP, FDA, EMA regulatory requirements

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter