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Senior Manufacturing Project Lead

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 9 August 2026 (30+ days ago)

Application Deadline: 6 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

Be the engine behind scalable compliant and efficient biologics manufacturing. As a Senior Manufacturing Project Lead youll drive operational readiness lead on-the-floor support and ensure seamless tech transfers in a 24/7 facilityshaping how life-changing therapies reach patients faster and more reliably.

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

At Fujifilm Biotechnologies were building a best-in-class biomanufacturing operation grounded in safety quality and collaboration. We partner closely across functions and with clients to deliver exceptional results. This role sits within Manufacturing (DSM) and reports to the Manufacturing Compliance & Support Manager. Youll join a team that values continuous improvement clear communication and inclusive leadershipwhere your ideas and expertise help set the pace for our growth.

Note: This facility operates 24/7. The role may require flexibility with working hours and shift rotation.

Responsibilities

Lead operational readiness initiatives for new and expanding operations.
Drive site commissioning and qualification efforts.
Manage cost and schedule execution for project delivery items and manufacturing operational projects.
Support organization and development of operational readiness plans and documentation.

Lead manufacturing-focused projects at the request of leadership.
Collaborate to meet needs and expectations for Factory X initiatives and other cross-site projects.
Support materials management activities within manufacturing.
Drive column packing and changeover activities including authoring and updating related documents.
Lead manufacturing support deliverables including:
Manufacturing change controls and corrective and preventive actions (CAPAs)
Short-flow investigations and management of alert/action limits
Development and maintenance of finite manufacturing schedules
Continuous improvement initiatives escalation and mitigation of manufacturing issues
Cross-site or local manufacturing projects
Technology transfer manufacturing deliverables
Assistance during regulatory inspections and audits
Network across disciplines and adapt communication style to influence outcomes tied to broader business goals.
Provide guidance on complex matters; contribute to delivery of tactical business targets through teamwork.
Work primarily on tech transfer and on-the-floor support to ensure right-first-time execution.

Minimum Qualifications

One of the following education/experience pathways:

High school diploma/GED with 12 years of related experience; or
Associate degree in life sciences or engineering with 10 years of direct experience; or
Bachelors degree in life sciences or engineering with 8 years of direct experience; or
Equivalent military experience/training

Previous experience in a cGMP manufacturing environment
Relevant experience in CAPEX/OPEX projects
Ability to lead teams facilitate workshops and communicate project status effectively
Experienced in campaign lifecycle activities
Understanding of manufacturing equipment operations and cadence
Strong communication time management critical thinking and problem-solving skills
Ability to adapt in a fast-paced environment pivot and adjust plans; team-oriented and effective in a global environment

Preferred Qualifications

BioWorks or BTEC Capstone cGMP coursework

We offer a comprehensive market-competitive total rewards package designed to support your wellbeing and growth which typically includes:

Competitive base pay with performance incentives
Medical dental and vision coverage; HSA/FSA options
Retirement savings plan with company contribution
Paid time off company holidays and paid parental leave
Flexible work practices where role-appropriate with shift differential where applicable
Employee Assistance Program and wellbeing resources
Professional development training and tuition support
Inclusive culture with recognition programs and opportunities to contribute to cross-site initiatives

We are an equal opportunity employer. We welcome applicants of all backgrounds and provide reasonable accommodations throughout the hiring process upon request. If youre energized by leading complex manufacturing projects enabling smooth tech transfers and supporting on-the-floor excellence wed love to hear from you.

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 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.

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:

Senior IC

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About Company

Fujifilm

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