Associate Director, Engineering

medhunter.de

Rahway, NJ, USA
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
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Gmp clinical supply facility experience
Equipment start-up and qualification
Small molecule or biologics process development
** The Associate Director of Engineering position at medhunter.de in Rahway, NJ, seeks a candidate to lead a team in the Modality Agnostic Chemistry Scaleup Operations group, focusing on technical mentorship and project management within a new GMP clinical manufacturing facility. The role involves collaboration across departments to ensure the successful startup and operation of the facility slated for completion by 2027. **

Job Summary

  • The Associate Director will build and lead a team of 5-10 engineers to support the MACS Center, a new potent, multi-modality drug substance development and GMP clinical manufacturing plant in Rahway, New Jersey.
  • This role requires establishing requirements for the first-of-a-kind facility by the ready for science target date of 2Q 2027 while contributing to equipment design and system commissioning.
  • The successful candidate will be eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 75

** The Associate Director of Engineering position at medhunter.de in Rahway, NJ, seeks a candidate to lead a team in the Modality Agnostic Chemistry Scaleup Operations group, focusing on technical mentorship and project management within a new GMP clinical manufacturing facility. The role involves collaboration across departments to ensure the successful startup and operation of the facility slated for completion by 2027. **

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive available; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • GMP clinical supply facility experience
  • Equipment start-up and qualification
  • Small molecule or biologics process development
  • Leading compliance investigations and change management
  • Process Hazard Analysis (PHA) and LOPA
  • Building high performance engineering teams

Nice-to-have

  • GMP facility design and commissioning experience
  • Potent compound processing and containment systems
  • Experience with automation systems like DeltaV or PLC
  • Managing process utility systems such as WFI and chillers
  • Coordinating maintenance activities around processing

Key Requirements

  • Bachelor's degree with 8 years experience or Master's with 7 years or PhD with 5 years
  • Experience in GMP clinical supply facility operations
  • Experience with equipment start-up and qualification
  • Familiarity with US and EU GMP and Safety compliance regulations
  • Ability to prepare Standard Operating Procedures (SOP) and cGMP documents

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter