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

Newyorkbioconnect

Rahway, New Jersey, USA
$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 Newyorkbioconnect is responsible for overseeing clinical supply manufacturing in an oral solid dosage environment, focusing on quality and efficiency. The position requires extensive experience in GMP manufacturing, process engineering, and team leadership, while offering a competitive salary and a hybrid work model. **

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 Newyorkbioconnect is responsible for overseeing clinical supply manufacturing in an oral solid dosage environment, focusing on quality and efficiency. The position requires extensive experience in GMP manufacturing, process engineering, and team leadership, while offering a competitive salary and a hybrid work model. **

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

  • Foster culture of collaboration
  • Drive innovation and learning
  • Subject matter expert in drug delivery
  • Evaluate new technologies
  • Hands-on 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 supporting or leading GMP manufacturing facilities
  • Experience authoring, reviewing and approving batch records
  • Experience with quality investigations and change controls
  • Proven track record in fast-paced environment
  • Demonstrated ability of independent problem-solving

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter