Position Overview

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.

Job Description

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.

What you'll lead

• Strategy and operating system
  • 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.

• Mammalian tech transfer, validation, and stewardship
  • 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.

• Investigation excellence and compliance
• 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.

• Cross-functional execution and portfolio leadership
• 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.

• Performance management and business outcomes
• 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.

• Culture, leadership, and talent
  • 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.

Minimum education and experience 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

Preferred education and experience

• 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

What you'll bring to succeed

• 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.

Work model and scope

• Site-based leadership role supporting a 24/7 manufacturing facility; on-call eligible and designated for inclement weather operations.
• Leads through subordinate leaders with approximately 4-5 direct reports and 12-30 indirect reports.

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k)savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.