Senior Director, MSAT

Fujifilm•Holly Springs, NC

7d•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 largest end-to-end mammalian cell culture CDMO drug substance operation in North America. We’re seeking an entrepreneurial Senior Director to lead our Drug Substance MSAT pillar from greenfield start-up through stable, scalable GMP manufacturing. This is a high-impact, senior leadership role for a proven MSAT executive who can set vision, build world-class teams, and deliver flawless tech transfer, PPQ, and commercialization across 24/7 operations.

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.