Associate Director, Engineering - Sterile Production Lead

Muckelab

Rahway, New Jersey, USA
Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Aseptic drug product manufacturing
Aseptic filling lines
Isolators and lyophilizers
The Associate Director, Engineering will lead the end-to-end operational strategy, execution, and performance of the FLEx Sterile facility, shaping the operational culture from the ground up

Job Summary

  • The Associate Director, Engineering will lead the end-to-end operational strategy, execution, and performance of the FLEx Sterile facility, shaping the operational culture from the ground up.
  • Key responsibilities include building the Operations organization, partnering with engineering and quality for C&Q alignment, establishing GMP-compliant operating procedures, and owning operational readiness for aseptic manufacturing.
  • Success will be measured by the facility's transition to cGMP operations on schedule, a high-performing and compliant operations team, timely delivery of clinical batches, and an active continuous improvement pipeline.

Matching Summary

The Associate Director, Engineering will lead the end-to-end operational strategy, execution, and performance of the FLEx Sterile facility, shaping the operational culture from the ground up.

Salary

Base: $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

  • aseptic drug product manufacturing
  • aseptic filling lines
  • isolators and lyophilizers
  • cGMP and aseptic processing
  • operational excellence methodologies
  • cross-functional collaboration

Nice-to-have

  • patient-centric environment
  • continuous learning culture
  • data-driven decision-making
  • consultative skills
  • problem-solving aptitude

Key Requirements

  • Bachelor's degree with 8 years of experience
  • Master's degree with 6 years of experience
  • PhD degree with 4 years of experience
  • Minimum 8 years relevant experience
  • Minimum 4 years leadership experience
  • Must have relevant work authorization

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter