Senior MSAT Leader - Drug Substance & Tech Transfer

FUJIFILM Holdings America Corporation; Holly Springs (MS); On-site; USD 180,000 - 240,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Associate Director, Drug Substance MSAT, to lead end-to-end process stewardship for upstream and downstream operations across a large-scale bioreactor and purification platform.

You will drive MSAT strategy, build a high-performing team, partner across Manufacturing, QA, Automation, and Engineering, and oversee tech transfer, PPQ, CMC contributions, and continuous improvement to ensure compliant, on-time drug substance delivery.

Qualifications

• Master’s or Bachelor’s degree in Engineering or Science with 9+ or 11+ years of experience.
• 8+ years of people management/leadership experience.
• 9+ years of CMC experience leading pre- and post-approval activities for biologic product, GMP.

Responsibilities

• Owns end-to-end technical strategy execution for drug substance from tech transfer through commercialization for upstream and downstream platforms.
• Assigns and coaches scientists/engineers; directs TT readiness activities; monitors performance and resolves concerns.
• Sets direction for process control strategy by translating CQAs into CPPs, ranges, and control plans.
• Ensures process flow diagrams, change controls, and related documents stay current.
• Drives continuous improvement to enhance manufacturability, reliability, quality, and cost.
• Authors CMC sections of regulatory filings and supports regulatory interactions as required.
• Coordinates cross-functional delivery with Manufacturing, QA, Automation, Engineering, and Supply Chain.

Skills

MSAT leadership

Process stewardship

Team leadership

Technical strategy

Cross-functional collaboration

Education

Master's degree in Engineering or Science

Bachelor's degree in Engineering or Science

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Associate Director, Drug Substance MSAT, to lead end-to-end process stewardship for upstream and downstream operations across a large-scale bioreactor and purification platform.

You will drive MSAT strategy, build a high-performing team, partner across Manufacturing, QA, Automation, and Engineering, and oversee tech transfer, PPQ, CMC contributions, and continuous improvement to ensure compliant, on-time drug substance delivery.