Director, Drug Substance MSAT & Process Excellence

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

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking an Associate Director, Drug Substance MSAT, to lead end-to-end process stewardship for DSM1/DSM2. You will drive MSAT strategy, build a strong team of scientists and engineers, and optimize large-scale cell culture and purification operations from TT to commercialization.

The role requires extensive CMC experience, leadership, and a track record in biologics development, process validation, and regulatory interactions.

Qualifications

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

Responsibilities

• Assigns and coaches upstream/downstream scientists and engineers; directs TT readiness activities and reviews performance.
• Owns product and process stewardship from NPI through commercialization for upstream and downstream.
• Sets direction in process control strategy by translating product CQAs into CPPs, ranges, and control plans.
• Ensures process flow diagrams, change controls, and related documents remain current.
• Drives continuous improvement to enhance manufacturability, reliability, and quality.

Skills

People leadership

CMC experience

Biologic process development

Education

Master’s degree in Engineering or Science

Bachelor’s degree in Engineering or Science

Job description

FUJIFILM Biotechnologies in North Carolina is seeking an Associate Director, Drug Substance MSAT, to lead end-to-end process stewardship for DSM1/DSM2. You will drive MSAT strategy, build a strong team of scientists and engineers, and optimize large-scale cell culture and purification operations from TT to commercialization.

The role requires extensive CMC experience, leadership, and a track record in biologics development, process validation, and regulatory interactions.