Associate Director - Cell Culture Development & Commercialization

med-in.at

$142,400.00 - $224,100.00; bonus + long-term incen...
Hybrid (3 days on-site, 1 day remote)
Cell culture process development
Biologics commercialization
Regulatory filings support
med-in.at is seeking an Associate Director for Cell Culture Development & Commercialization, focusing on leading and advancing their late-stage biologics pipeline. The ideal candidate should possess extensive experience in cell culture processes, regulatory submissions, and team leadership, with a strong emphasis on collaboration and innovation

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

med-in.at is seeking an Associate Director for Cell Culture Development & Commercialization, focusing on leading and advancing their late-stage biologics pipeline. The ideal candidate should possess extensive experience in cell culture processes, regulatory submissions, and team leadership, with a strong emphasis on collaboration and innovation.

Salary

$142,400.00 - $224,100.00; Bonus and long-term incentive eligibility; Comprehensive benefits package

Skills & Requirements

Must-have

  • Cell culture process development
  • Biologics commercialization
  • Regulatory filings support
  • Process validation
  • Cross-functional collaboration

Nice-to-have

  • Strategic technical direction
  • Action-oriented mindset
  • Culture of diversity and inclusion
  • Business improvement initiatives

Key Requirements

  • 8 years relevant industry experience (Bachelor's)
  • 6 years relevant industry experience (Master's)
  • 3 years relevant industry experience (PhD)
  • Support/write regulatory filings (IND, MAA, BLA)
  • Support inspections with multiple agencies

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter