**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. **Check out the FDB Holly Springs Site! (https://www.streamio.com/api/v1/videos/64df84ca6f8d8df16d000001/public\_show?player\_id=5d136e976f8d8d57e6000009&link=true)** **External US** **About This Role** _During the project phase (Through Mid-2025)_ • Provides oversight and leads operational readiness projects including but not limited to leads the creation or transfer, from existing large-scale facility, Manufacturing Support team business processes to ensure good manufacturing practice (GMP) operational readiness • Leads, manages, and builds manufacturing support team • Enforces company policies and procedures that directly impact employees (e.g., PTO, inclement weather, etc.) • Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.) • Performs other duties, as assigned _In operations (Staring Mid-2025)_ • Supervises the Manufacturing Support team and sets the direction for individual and team goals • Oversees and coordinates the tasks of the Manufacturing Support team • Fosters an inclusive, people-first culture by creating meaningful development plans with direct reports and conducting 1:1s and skip levels on a defined cadence • Provides coaching and support to direct reports and team members to foster professional development and growth • Acts as functional lead for regulatory inspections and audits • Provides oversight on the coordination of non-batch activities and collaborate cross functionally, including but not limited to: + Owns manufacturing change controls and CAPAs + Short flow investigations and alert/action limits + Detailed batch manufacturing schedules + Campaign materials management + Manages Manufacturing training and curricula •Provides direction or resolution to escalations (e.g., risks, issues, etc.) •Leads the development and implementation of continuous improvement initiatives •Enforces company policies and procedures that directly impact employees (e.g., PTO, inclement weather, etc.) •Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.) •Manages functional area budget and monitors fiscal year performance •Addresses employee questions, concerns, performance, and partners with HR, as needed for resolution •Participates in the recruitment process to attract talent and provides input to develop retention strategies •Performs other duties as assigned **Basic Requirements** • Bachelor’s degree in Life Sciences, Engineering or related field with 10 years direct DPFG manufacturing experience, including deviations and CAPA, training, and SOP creation • 3-5 years of experience managing a team • Experience collaborating cross-functionally at the site and global level • Experience directly supporting aseptic drug product manufacturing **Preferred Requirements** • Master’s degree in Life Science or Engineering • Previous drug product, isolator start-up experience • Experience working in a changing, project driven organization • Lean Six Sigma or similar certification **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** + Ability to discern audible cues. + Ability to conduct work that includes moving objects up to 10 pounds. _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._ **Job Locations** _US-NC-Holly Springs_ **Posted Date** _3 weeks ago_ _(11/26/2024 2:02 PM)_ **_Requisition ID_** _2024-32680_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_