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Senior Director, MSAT

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 27 September 2026 (22 hours ago)

Application Deadline: 25 December 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

As a candidate you bring in deep expertise across mammalian manufacturing (upstream and downstream) large-scale cell culture and MSAT operating systemspaired 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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

FUJIFILM Biotechnologies is building the largest end-to-end mammalian cell culture CDMO drug substance operation in North America. Were 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 youll lead

Strategy and operating system
- Set the end-to-end MSAT strategy for DSM1DSM4; 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

Masters degree (preferred) in an Engineering or Scientific field with 10 years of direct experience; OR
Bachelors 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 youll 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 45 direct reports and 1230 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 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. Theorganisationis committed to beingtransparent about how it collects and uses that dataand to meeting its data protection obligations and may share this as part of the global recruitment process with hiringmanagers 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 atFUJIFILM 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 thisrequisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of anykind will be paid.

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 ().

Required Experience:

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Fujifilm

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