The Senior Manufacturing Project Lead will lead and organize 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 Diosynth 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: https://www.fujifilm.com/us/en/about/region/careers

What You’ll Do

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 

In Operations:

• 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.

Basic Requirements

• High School Diploma or GED
• 12 years of related experience

Preferred Requirements

• Associate’s Degree in Life Sciences or Engineering + 10 years of direct experience OR
• Bachelor’s degree in life sciences or engineering + 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 effectively communicate project status
• Experience in campaign lifecycle activities
• Understanding of manufacturing equipment, operations, and cadence
• BioWorks or BTEC Capstone cGMP coursework preferred  

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS  

• 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 wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.

ENVIRONMENTAL CONDITIONS

• Will work in heights greater than 4 feet

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.

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 (FDBN_PNC@fujifilm.com).