Senior Director, MSAT - Scale-Up Biologics Leader

FUJIFILM; Holly Springs (MS); On-site; USD 250,000 - 320,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Health Savings Account with company

401(k) plan with company contributions

Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies is seeking a Senior Director to lead the Drug Substance MSAT pillar from greenfield start-up through commercial GMP manufacturing in North America. This role requires executive leadership, a strong client-facing presence, and the ability to drive flawless tech transfer and PPQ across 24/7 operations.

You will build world-class teams, set strategy, and partner with cross-functional groups to deliver biosubstance programs while maintaining safety, quality, and regulatory

Qualifications

• Master’s or Bachelor’s in Engineering/Science with 10+ or 12+ years in drug substance manufacturing
• 10+ years of people management, leadership, and team management experience
• 10 years of CMC experience leading pre- and post-approval activities for biologics
• Experience in a cGMP facility or with FDA regulations
• Demonstrated experience ramping up billion-dollar greenfield facilities

Responsibilities

• Define end-to-end MSAT strategy for DSM1–DM4 and translate into objectives, roadmaps, and KPIs.
• Lead tech transfer readiness and PPQ delivery for scale and commercialization.
• Oversee deviations, investigations, CAPAs, and ensure timely inspection/audit readiness.
• Align cross-functional teams (Manufacturing, QA, Engineering, Supply Chain) on schedules and capital projects.
• Set performance targets and sponsor major capital projects tied to throughput and capability expansion.

Skills

MSAT leadership

Mammalian cell culture

Executive presence

Client-facing

Strategic planning

Education

Master’s degree in Engineering or Science

Bachelor’s degree in Engineering or Science

Job description

FUJIFILM Biotechnologies is seeking a Senior Director to lead the Drug Substance MSAT pillar from greenfield start-up through commercial GMP manufacturing in North America. This role requires executive leadership, a strong client-facing presence, and the ability to drive flawless tech transfer and PPQ across 24/7 operations.

You will build world-class teams, set strategy, and partner with cross-functional groups to deliver biosubstance programs while maintaining safety, quality, and regulatory