Senior Manufacturing Project Lead

Position Overview

Be the engine behind scalable, compliant, and efficient biologics manufacturing. As a Senior Manufacturing Project Lead, you'll drive operational readiness, lead on-the-floor support, and ensure seamless tech transfers in a 24/7 facility-shaping 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, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're 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 we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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:

Job Description

At Fujifilm Biotechnologies, we're 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. You'll join a team that values continuous improvement, clear communication, and inclusive leadership-where 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

Project Phase

• 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.

In Operations

• 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
• Bachelor's 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

Benefits

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 you're energized by leading complex manufacturing projects, enabling smooth tech transfers, and supporting on-the-floor excellence, we'd 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 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.

EEO Information

Fujifilm is committed to 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 (View email address on hirelifescience.com).