Associate Director, Drug Substance MSAT

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us deliver the next vaccine, cure, or therapy in a dynamic work environment that fuels purpose, energy, and drive—what we call Genki.

About the role

The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). This role executes MSAT strategy, builds and develops a team of scientists and engineers, and optimizes large-scale cell culture operations across seed/production bioreactors and purification trains. With a focus on innovation and reliability, this leader drives technical stewardship through tech transfer execution, process performance qualification (PPQ), commercialization, and continuous improvement initiatives. The Associate Director partners closely with MSAT leadership, Manufacturing, QA, Automation, and Engineering to improve systems and working methods, and serves as the suite’s technical owner in client forums.

Responsibilities

• Assigns and coaches upstream/downstream scientists, engineers, and team members; directs technical leads for tech transfer (TT) execution and readiness activities; reviews performance and partners with HR as needed for resolution
• Owns product and process stewardship by leading end-to-end technical strategy execution for assigned products in the suite from new product introduction through commercialization, covering upstream (seed/production bioreactors) and downstream (purification trains)
• Sets direction in defining and maintaining the process control strategy by translating product critical quality attributes into upstream/downstream critical process parameters, acceptable ranges, and control plans
• Ensures process flow diagram, change controls, and associated documents remain current
• Maintains floor presence, safety, and compliance; ensures successful manufacturing process comparability and validation runs
• Drives continuous improvement projects to enhance manufacturability, reliability, efficiency, quality, cost, and compliance
• Establishes systems and procedures for proactive process monitoring, analysis, and reporting of manufacturing process data (within batch and batch-to-batch)
• Promotes professional development, psychological safety, accountability, personal ownership, and proactive problem-solving; runs effective tier huddles; recognizes contributions and shares learnings (Yokoten)
• Oversees critical manufacturing investigations and deviations; reviews trends, capability, and alarms; determines true root cause; initiates, oversees, and verifies corrective and preventive actions (CAPAs); authors and approves change controls
• Authors Chemistry, Manufacturing, and Control (CMC) sections of regulatory filings; supports CMC review of regulatory submissions, site inspections, and health authority inquiries
• Partners with Client, Process Development, Quality, Manufacturing, and Engineering on large-scale platform development, technology innovation, scale-up, and manufacturability as part of tech transfer
• Coordinates cross-functional delivery by collaborating with Manufacturing, Quality, Automation, Engineering, Supply Chain, and other support groups to align schedules, resources, and decisions under tiered governance; utilizes clear decision rights (D.A.I model)
• Functions as a senior leader to support supplier technical evaluations, risk assessments, raw material evaluations, and qualifications
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports)
• Participates in the recruitment process and retention strategies to attract and retain talent
• Performs other duties, as assigned

Requirements

• Master’s degree in an Engineering or Scientific field with 9+ years of experience OR 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 Good Manufacturing Practices (GMP)

Preferred Qualifications

• 12+ years of experience in a similar role with large projects from conceptual design phase to operations
• 8+ years of experience leading technical departments
• Technical leadership experience with drug substance manufacturing facilities
• Prior drug substance development and manufacturing experience including process validation, process transfer, commercialization, manufacturing support, and troubleshooting drug substance operations
• Experience communicating and collaborating with a global team

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, offering the perfect blend of community and opportunity.