The Staff Process Engineer, (internally known as Staff Validation Engineer) is a high-level position in the MT&S department of FDBU.  This position will directly report to the Associate Director of Manufacturing Technology and Support, but may also have a functional reporting relationship to a senior colleague on a project to project basis.

The Analytical Method Transfer (AMT) group in our Morrisville, NC location is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs.  The AMT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.

The Analytical Method Transfer group is seeking an Associate Scientist with protein chemistry experience. The AMT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.

Summary This position requires working 2nd shift. The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in these production process units.

The Master Scheduler is responsible for the maintenance of the Production Plan in the ERP system to support the MRP (Material Requirement Planning) process. Responsible for providing the Supply Chain team with a monthly production plan consistent with the asset / production plan and forecasted demands. New business opportunities, customer expectations, internal supply requests, and internal supply constraints will be used to load the production plan in ERP system for a defined period. Strong collaboration with Operations and Supply will be critical to meeting the business objectives.

Summary:  This position requires working 2nd shift. Under limited supervision of the Sr. Manager, Materials Management, the Materials Specialist II is responsible for the accurate receipt, verification, record keeping, distribution, and shipment of materials and goods.

Summary: This position requires working 2nd shift. The Materials Management Specialist is responsible for drafting and implementing supply chain management procedures governing the receiving, warehousing, ordering, shipping and internal distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials.

Summary: This positon requires working 2nd shift.   The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

Summary: This position requires working 2nd shift.   The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

Summary: This position requires working 2nd shift. The Manufacturing Technician II work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following: - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

Summary:  This position requires working 2nd shift. The Manufacturing Technician I work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:   - Upstream Unit: - Single-Use Cell Culture Vessels/Bioreactors up to 2000L - Bacterial Fermentation Culture Vessels up to 2000L - Alpha Wasserman Continuous Flow Centrifuges - Disposable Magnetic Mixing Bags and Totes - Cell Expansion and Propagation - Banking/Cryopreservation of Cell Lines and Viruses - Hyperstack, Cellstack, and other Adherent Cell Technologies - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Downstream Unit: - Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration - Medium to Large-scale Chromatographic systems (ÄKTA). - Pre-Packed Columns from 1L to 100L - Single use mixing systems (Pall & GE) - Single Use connectivity types such as GE DAC and Colder AseptiQuik - Bulk filling - Aseptic process simulation and drug product filling - Plate counting, microscopic examination - Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation - Buffer Preparation Unit: - Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs - Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures - Integrity testing of filters

The QA Manager for Product Release and Operations is responsible for specific quality and compliance areas within Quality Assurance for a site. They will manage Quality Assurance systems and staff to meet site quality and compliance expectations. Other responsibilities include being a customer liaison, acting as the project compliance lead for manufacturing readiness (including process validation programs), being the Quality SME during customer audits and health authority inspections, and quality oversight for batch record review, deviation review and closure, managing customer requirements, and final product quality decisions. 

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) is seeking a Process Engineer within the Engineering department.  The successful candidate will support capital and operational projects with equipment design, commissioning, FAT/SAT testing and installation.  Working with the other functions within engineering, the position will ensure deliverables for his/her respective projects are well managed and in line with their stakeholders expectations. FDBU Engineering consists of project, process, automation, and lab analytical responsible for both capital and operational projects in support of manufacturing, process development, and facilities/maintenance.

Summary:  The Manufacturing Manager, Upstream – NCTM is responsible for assisting in the planning, directing, and coordinating of the activities related to the Upstream manufacturing processes for the National Center for Therapeutics Manufacturing (NCTM) while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics.  The Manufacturing Manager, Upstream will oversee the cGMP production and Upstream manufacturing systems working directly with cell culture and viral propagation techniques, cell culture and bioreactor operations, bacterial and fermentation operations, pDNA, protein, and yeast related operations, and aseptic techniques while following cGMP procedures.

We are seeking a team of Senior Process equipment Engineers in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji Film have ever entered. Be a part of the future. Today.   We offer the possibility of playing a central role in the Process Equipment work package in a a $2 billion global project. Your specialist focus could be on Upstream, downstream, media/prep, CIP/water etc. depending on your background.

We are seeking a Head of Building Drug Product and Finished Goods Manufacturing in our journey to establishing the largest End-to-End cell culture CDMO plant in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji film have ever entered. Be a part of the future. Today.   You as the Head of Building Drug Product and Finished Goods Manufacturing will be responsible for setting the direction and managing the engineering and construction activities for the new facilities in a $2 billion global project. We offer the possibility of creating and leading the CSA team, and you will act as the leader of the team and work package owner with your management skills strong CSA background. The focus of the job will be on either Drug products (DP), Drug substance manufacturing (DSM) or finish good manufacturing (FGM). You will be responsible for securing that the future buildings are structured, designed, engineered and constructed in a way that lives up to the expectations of future operations.

We are seeking a Head of Building, Drug Substance Manufacturing in our journey to establishing the largest End-to-End cell culture CDMO plant in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji film have ever entered. Be a part of the future. Today.   You as the Head of Building, Drug Substance Manufacturing will be responsible for setting the direction and managing the engineering and construction activities for the new facilities in a $2 billion global project. We offer the possibility of creating and leading the CSA team, and you will act as the leader of the team and work package owner with your management skills strong CSA background. The focus of the job will be on either Drug products (DP), Drug substance manufacturing (DSM) or finish good manufacturing (FGM). You will be responsible for securing that the future buildings are structured, designed, engineered and constructed in a way that lives up to the expectations of future operations.

We are seeking a Head of Finance in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji Film have ever entered. Be a part of the future. Today.   You as the Head of finance will be responsible for setting the direction and managing the Finance activities in a $2 billion global project. We offer the responsibility of building and driving the finance function in the Galaxy project – overseeing the finance and accounting transactions in the project and providing a transparent overview of the financial results.    We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace for people driven to make a difference.

We are seeking a Head of Environmental, Social, and Governance (ESG) Sustainability in our journey to establishing the largest End-to-End cell culture CDMO provider in North America but more importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. Be a part of the future. Today.   You as the Head of ESG (Sustainability) will drive the ESG strategy and its execution in a $2 billion global project. We offer the opportunity to be part of a journey where FUJIFILM strives to be a model company for life science/biotech manufacturing globally by pursuing zero environmental impact and work with the local community in resolving environmental and social issues. You will collaborate and coordinate across functions, and be responsible for ensuring that the entire project deliver on ESG/sustainability.