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Senior ManagerAssociate Director, Drug Substance MSAT

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 22 August 2026 (22 days ago)

Application Deadline: 22 November 2026

Vacancies: 1 Vacancy

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Job Summary

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 suites 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 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

What Youll 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:

Masters degree in an Engineering or Scientific field with 9 years of experience OR
Bachelors 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 ().

Required Experience:

Director

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About Company

Fujifilm

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