Senior Director, MSAT

Fujifilm • Holly Springs, NC

5d • Onsite

About The Position

As a candidate you bring in deep expertise across mammalian manufacturing (upstream and downstream), large-scale cell culture, and MSAT operating systems—paired with executive-level leadership, client-facing presence, and a track record of ramping greenfield facilities to commercial performance. Make an impact and lead a large-scale mammalian drug substance operation from greenfield to sustained commercial excellence. Partner with the Site Leadership Team to shape the strategy, people and platforms that define best-in-class MSAT and manufacturing performance. Partner with Operations, Quality, Engineering, Automation and Supply Chain to deliver life-changing biologics to our patients across the globe. 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

Requirements

• Master’s degree (preferred) in an Engineering or Scientific field with 10+ years of direct experience; OR Bachelor’s degree in an Engineering or Scientific field with 12+ years of direct experience in drug substance manufacturing (e.g., downstream/upstream)
• 10+ years of people management, leadership, and team management experience
• 10 years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and GMP
• Experience in a cGMP facility or working with FDA regulations
• Demonstrated experience in the successful ramp-up of billion-dollar green field facilities
• Deep MSAT pillar leadership with mammalian cell culture expertise across upstream and downstream, scale-up/scale-out, and commercial operations.
• Executive presence with strong client-facing communication; able to influence across site leadership, steering committees, and governance forums.
• Proven ability to build high-performing teams, standardize platforms (buffers, unit operations, recipes), and implement digital/PAT solutions that boost yield, robustness, and cost efficiency.
• Strong command of US/international regulatory standards and ICH guidelines; exceptional investigation/RCA/CAPA rigor.
• Solution-oriented, data-driven mindset with the ability to operate in fast-paced, 24/7 GMP environments.

Nice To Haves

• 12+ years of experience from similar role in large projects to GMP operations
• 8+ years of experience leading technical departments, specifically with drug substance manufacturing facilities

Responsibilities

• Set the end-to-end MSAT strategy for DSM1–DSM4; translate into clear objectives, roadmaps, and KPIs from tech transfer through commercial lifecycle.
• Define and govern the process control strategy linking CQAs to CPPs; establish ranges, control plans, and alignment with Manufacturing, Quality, and Engineering.
• Institutionalize a tiered governance model, leader standard work, pre-/in-/post-flight controls, process monitoring boards, and escalation pathways to ensure proactive risk management and stable operations.
• Own product and process stewardship for assigned programs from late-stage tech transfer through commercial lifecycle management, including process monitoring to hit yield, robustness, quality, cost, and supply reliability targets.
• Lead PPQ readiness and delivery; drive digital/PAT adoption and continuous improvement for scale, repeatability, and cost efficiency.
• Oversee complex deviations and manufacturing investigations; ensure rigorous root cause analysis, effective CAPAs, trending, and systemic fixes.
• Ensure inspection/audit readiness; lead technical strategy presentations and close observations on time.
• Align Manufacturing, QA, Engineering, Supply Chain, and Automation on finite schedules, resource plans, shutdowns/turnarounds, and capital projects; chair/co-chair tier councils.
• Manage portfolio and client commitments; prioritize programs, negotiate scope/timelines, and provide executive-level status updates to meet SOW commitments.
• Set and review performance targets (e.g., tech transfer P&L, right-first-time, batch success rate, deviation recurrence, PPQ/pipeline delivery, and regulatory/audit outcomes); publish dashboards and lead operating reviews.
• Make build/partner/buy recommendations (analytical, PAT, single-use, automation tooling) and sponsor major capital projects tied to throughput and capability expansion.
• Oversee raw material and resin strategy with Supply Chain/QA; risk-assess critical materials, approve qualification plans, and ensure business continuity and buffer stocks.
• Build and develop a high-performing MSAT organization through subordinate leaders; drive org design, succession planning, and talent strategies.
• Foster a culture of psychological safety, ownership, and continuous improvement; coach leaders and teams to deliver reliable, compliant results.
• Champion EHS and Quality culture; ensure hazard/risk assessments and adherence to cGMP, data integrity, and documentation standards.

Benefits

• medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions
• industry leading 401(k)savings plan
• insurance coverage
• employee assistance programs
• various wellness incentives
• paid vacation time, sick time, and company holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Director