**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** This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. While in project phase, the schedule will be Monday-Friday during normal business hours. Upon transitioning to operations, this position will transition to a day or night shift that will be defined prior to the transition. **What You’ll Do** _During Project Phase:_ + Key contributor in supporting the preparation for operational readiness related to bulk drug substance manufacturing. + Supporting projects related to: + Commissioning and qualification of equipment, procedure review and/or creation, support onboarding of manufacturing staff, development or Transfer of Manufacturing business processes, new item creation, or single-use assembly transfer or design. + 0-25% travel (international and/or domestic) may be required. _In Operations:_ + Adhere to strict safety protocols and contribute to culture of safety within the manufacturing environment. Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control within a functional area, ensuring compliance with Standard operating procedures (SOPs) and cGMP regulations. + Oversee and/or perform in-process testing (pH, conductivity, visual inspection) + Execute validation protocols. Provide approval as a backup to the supervisor. + Maintain training to perform all required activities. + Train and mentor junior manufacturing associates to enhance team capabilities. + Support scheduling daily activities on the manufacturing floor and act as a back-up for the supervisor, as needed. + Lead troubleshooting as required for operational issues. + Assist the supervisor with shift huddles and tier escalations, investigation, and continuous improvement (CI) projects, as needed. + Area lead for cycle counts and materials management. + Other duties as assigned. + This role requires shift work (weekend and potential for nights). **Who You Are** You have strong troubleshooting ability as well as verbal and written communication skills. You have the ability to adapt in a fast-paced changing environment, pivot and adjust plans accordingly. You have strong time-management skills and are able to think critically with superior problem-solving skills. You have a team-based attitude and the ability to work in a global team environment by building relationships while communicating effectively with others. **Basic Requirements** + 8 Years of experience in life sciences manufacturing with a High School Diploma or GED OR + 6 Years of experience in life sciences manufacturing with an Associate's Degree OR + 4 Years of experience in life sciences manufacturing with a Bachelor's Degree OR + Equivalent Military Experience **Preferred Requirements** + Associate’s Degree + BA/BS Degree, preferably in Life Sciences or Engineering + Proficient understanding of cGMP regulations and pharmaceutical industry standards + Fully qualified in a functional area (Ex: Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture or Purification) while also acting as an SME on all unit operations within that functional area (i.e. Inoc, Seed Train and Production Bioreactor) + BioWorks Certification **PHYSICAL REQUIREMENTS** **_PHYSICAL DEMANDS_** + Will work in environment which may necessitate respiratory protection + May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing 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 33 lbs. + Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. **_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** _3 weeks ago_ _(11/22/2024 7:49 AM)_ **_Requisition ID_** _2024-32441_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_