**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. **_*NOTE: This posting represents 3 openings*_** **External US** **About This Role** This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. **What You’ll Do** _Project Phase (Through Mid-2025)_ + Supports Factory Acceptance Testing (FAT) at the vendor site as required + Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable + Performs other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management + Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment + Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees _Operations Phase (Starting Mid-2025)_ + Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates + Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations + Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports + Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training + Supports manufacturing investigations and continuous improvement projects + Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment + Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees + Performs other job as assigned **Who You Are** You have a high degree of knowledge and expertise of the operation of production equipment in their respective functional area. You have an understanding of manufacturing run cadence and order of shift activities. You have expertise in cGMP, safety and FDBN operational procedures. You have a strong cross functional partnership with Quality, Process Sciences, Process Engineering and others. You are able to create and maintain a collaborative and inclusive team. You have the ability to travel and have a valid passport. **Basic Requirements** + High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects **Preferred Requirements** + BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects **OR** + Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects **OR** + Military Experience of equivalence + Experience in manufacturing of biological products, familiar with GMP/GLP requirements + Previous experience leading, supervising or managing others **PHYSICAL REQUIREMENTS** **_PHYSICAL DEMANDS_** + Will work in an environment which may necessitate respiratory protection + May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation program + Ability to discern audible cues **WORKING ENVIRONMENT** **_PHYSICAL DEMANDS_** + Ability to ascend or descend ladders, scaffolding, ramps, etc. + 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._ **Job Locations** _US-NC-Holly Springs_ **Posted Date** _5 days ago_ _(12/10/2024 9:51 AM)_ **_Requisition ID_** _2024-32771_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_