Associate Director - Cell Culture Development & Commercialization

leHACK

Rahway, New Jersey, US
Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid (3 days onsite, 1 day remote)
Cell culture process development
Process characterization
Regulatory filing support
leHACK is seeking an Associate Director for Cell Culture Development & Commercialization in Rahway, New Jersey. The ideal candidate will have extensive experience in biologics, particularly in cell culture processes, and will play a crucial role in leading commercialization efforts for late-stage biologics products

Job Summary

  • Provide strategic and tactical technical direction through cross-functional partnerships with key business units and customers.
  • Your leadership will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing sites, process validation, second generation process development and health authority licensure.
  • Collaborate with colleagues across the US and internationally to elevate standards in biologics commercialization and manufacturing.

Matching Summary

Match Score: 85

leHACK is seeking an Associate Director for Cell Culture Development & Commercialization in Rahway, New Jersey. The ideal candidate will have extensive experience in biologics, particularly in cell culture processes, and will play a crucial role in leading commercialization efforts for late-stage biologics products.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • Cell culture process development
  • Process characterization
  • Regulatory filing support
  • Biologics commercialization
  • Late stage biologics pipeline

Nice-to-have

  • Action-oriented mindset
  • Foster collaboration and transparency
  • Drive project schedules
  • Catalyst for innovation

Key Requirements

  • 8 years relevant industry experience (Bachelor's)
  • 6 years relevant industry experience (Master's)
  • 3 years relevant industry experience (Ph.D.)
  • Experience supporting regulatory filings (IND, MAA, BLA)
  • Experience supporting inspections with multiple agencies

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter