SR Manufacturing Project Lead Position Available In Wake, North Carolina

SR Manufacturing Project Lead
Job Locations
US-NC-Holly Springs
Posted Date
2 days ago
(4/17/2025 7:30 AM)
Requisition

ID 2025-34301

Category Manufacturing Company (Portal Searching)

FUJIFILM

Diosynth Biotechnologies
Position Overview
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.
Company Overview
Follow Your Genki to North America’s largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at

FUJIFILM

Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join

FUJIFILM

Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive – what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Job Description
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.
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 (FDBN_PNC@fujifilm.com).