Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB 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 FDB 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.
External US
About This Role
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.
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.
Who You Are
You have strong verbal and written communication skills. You have strong time management skills. You have the ability to adapt in a fast-paced environment, pivot and adjust plans accordingly. You have the ability to think critically and have superior problem-solving skills. You have a team-based attitude and ability to work in a global team environment, build relationships and communicate effectively with others.
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
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.