Senior Director, Mammalian MSAT Strategy & Scale-Up

FUJIFILM Electronic Materials (Europe) N.V.

Holly Springs (NC)

On-site

USD 180,000 - 280,000

Full time

10 days ago
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Benefits offered by this job

Medical, dental, vision coverage
401(k) savings plan
Paid vacation & holidays

Job summary

FUJIFILM Biotechnologies seeks a Senior Director to lead the Drug Substance MSAT pillar from greenfield start-up through stable, scalable GMP manufacturing across 24/7 operations. This is a high-impact, senior leadership role requiring an ability to set vision, build world-class teams, and drive flawless tech transfer, PPQ, and commercialization.

You will partner with Site Leadership and cross-functional teams to ensure robust process control, compliance, and continuous improvement, delivering

Qualifications

  • Master’s degree preferred in engineering or science with substantial leadership experience.
  • 10+ years in drug substance manufacturing or related MSAT leadership roles.
  • Demonstrated experience ramping greenfield facilities to commercial performance.

Responsibilities

  • Define end-to-end MSAT strategy for DSM programs and KPIs.
  • Lead tech transfer, PPQ readiness, and GMP manufacturing excellence.
  • Oversee investigations, CAPAs, and regulatory readiness (FDA/cGMP).
  • Align cross-functional teams (Manufacturing, QA, Engineering, Supply Chain) on schedules and capital projects.

Skills

MSAT leadership
Executive presence
Client-facing
Strategic planning

Education

Master’s or PhD in engineering/science
Bachelor’s in engineering/science

Job description

FUJIFILM Biotechnologies seeks a Senior Director to lead the Drug Substance MSAT pillar from greenfield start-up through stable, scalable GMP manufacturing across 24/7 operations. This is a high-impact, senior leadership role requiring an ability to set vision, build world-class teams, and drive flawless tech transfer, PPQ, and commercialization.

You will partner with Site Leadership and cross-functional teams to ensure robust process control, compliance, and continuous improvement, delivering

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