Associate Director, Drug Substance MSAT – End-to-End Leader

FUJIFILM; Holly Springs (NC); On-site; USD 140,000 - 210,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Associate Director, Drug Substance MSAT to lead end-to-end process stewardship for DSM1/DSM2. The role drives MSAT strategy, builds a strong team of scientists and engineers, and optimizes large-scale cell culture operations across seed/production bioreactors and purification trains.

The position requires 9+ years in CMC/biotech leadership, with a Master’s or Bachelor’s in engineering or science, and a track record of technical

Qualifications

• Master’s or Bachelor’s with extensive experience in drug substance operations.
• Experience leading large teams in biotech manufacturing environments.

Responsibilities

• Assigns and coaches upstream/downstream scientists, engineers, and team members; directs TT execution and readiness activities
• Owns product and process stewardship from NPI through commercialization for upstream and downstream
• Sets direction for process control strategy and translates CQAs into CPPs and control plans
• Ensures process flow diagrams, change controls, and related docs remain current
• Drives continuous improvement for manufacturability, reliability, efficiency, quality, cost, and compliance
• Establishes systems for proactive process monitoring and data reporting
• Promotes professional development, psychological safety, accountability, and proactive problem-solving
• Oversees investigations, deviations, CAPAs, and change controls
• Authors CMC sections of regulatory filings and supports regulatory interactions
• Partners with multiple functions for tech transfer, scale-up, and platform development
• Coordinates cross-functional delivery and governance across departments
• Participates in recruitment and retention strategies
• Performs other duties as assigned

Skills

MSAT leadership

People management

Project management

Upstream/downstream knowledge

Tech transfer

Regulatory awareness

Process optimization

Education

Master’s degree in Engineering/Science

Bachelor’s degree in Engineering/Science

Tools

GMP

CMC documentation

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Associate Director, Drug Substance MSAT to lead end-to-end process stewardship for DSM1/DSM2. The role drives MSAT strategy, builds a strong team of scientists and engineers, and optimizes large-scale cell culture operations across seed/production bioreactors and purification trains.

The position requires 9+ years in CMC/biotech leadership, with a Master’s or Bachelor’s in engineering or science, and a track record of technical