Drug Substance MSAT Lead

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 180,000 - 280,000; Full time

Job summary

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

You will partner with MSAT leadership, Manufacturing, QA, Automation, and Engineering to ensure compliant, on-time Drug Substance delivery.

Qualifications

• Master’s degree in Engineering or Scientific field with 9+ years of experience.
• Bachelor’s degree in Engineering or Scientific field with 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, including process development and GMP.

Responsibilities

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

Skills

Leadership experience

CMC knowledge

GMP compliance

Process development

Tech transfer

Education

Master’s degree in Engineering or Science

Bachelor’s degree in Engineering or Science

Job description

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

You will partner with MSAT leadership, Manufacturing, QA, Automation, and Engineering to ensure compliant, on-time Drug Substance delivery.