Sr. Manufacturing Project Lead

Sr. Manufacturing Project Lead role at FUJIFILM Biotechnologies

The Senior Manufacturing Project Lead leads and organizes manufacturing projects and support activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

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!

During the Project Phase

• Leads operational readiness initiatives as well as site commissioning and qualification efforts
• Manages cost and schedule execution of project delivery items and manufacturing operational projects
• Supports organization and development of operational readiness

• Leads manufacturing focused projects at the request of leadership
• Actively participates and collaborates to meet the need and expectations set forth by Factory X initiatives and other cross site projects, as assigned
• Supports materials management within manufacturing
• Drives column packing and changeover activities including the generation of documents
• Leads manufacturing support items which could include, but not limited to:
• Manufacturing change controls and corrective and preventive actions (CAPAs)
• Short flow investigations and alert/action limits
• Finite manufacturing schedules
• Continuous improvement, escalation, and mitigation of manufacturing issues
• Cross site or local manufacturing projects
• Technology transfer manufacturing deliverables
• Assist in regulatory inspections and audits
• Perform other duties as assigned

• 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 cGMP manufacturing environment
• Relevant experience in CAPEX/ OPEX projects
• Ability to lead teams, facilitate workshops and effectively communicate project status
• Experienced in campaign lifecycle activities
• Understanding of manufacturing equipment, operations, and cadence
• Bioworks or BTEC Capstone cGMP coursework preferred

• Ability to discern audible cues
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
• Will work in heights greater than 4 feet

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.

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 ().

Mid‑Senior level

Full‑time

Management and Manufacturing

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