Senior Manager/Associate Director, Drug Substance MSAT

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

Position Overview

The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). The 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) execution, commercialization, as well as continuous improvement initiatives. This leader partners closely with the rest of the MSAT leadership team, Manufacturing, QA, Automation, and Engineering to improve systems and working methods. The Associate Director serves as the suite’s technical owner in client forums, translating product requirement needs into clear plans, stage gates, and flawless execution to enable compliant, on time Drug Substance delivery.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By 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 realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive - what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do:

• Assigns and coaches upstream/downstream scientists, engineers, and team members; directs upstream/downstream technical leads for TT execution and readiness activities; reviews performance and concerns, 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


• Ensures floor presence, safety, and compliance as well as successful manufacturing process comparability and validation runs


• Drives continuous improvement projects to improve manufacturability, reliability, efficiency, quality, cost, and compliance


• Establishes systems and procedures to enable 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 the CMC review of regulatory submissions, site inspections, and health authority inquiries, as required


• 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 (TT), as needed


• 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, etc.)


• Participates in the recruitment process and retention strategies to attract and retain talent, as needed


• Performs other duties, as assigned

Minimum 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 Requirements:

• 12+ years of experience in 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

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).