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 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 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 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

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 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 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.

Summary:   The Director of Analytical Development is responsible for providing technical leadership in the area of virus-related vaccine and biotherapeutic technology transfer, development and in analytical methods development.  This individual will help deliver virally-based capability for current and future clients. 

The Associate Director of Engineering Science will conduct feasibility studies for consideration of large scale capital projects.  Will work with local governments on permitting for growth, building and architectural design, ordering supplies, and shipping and receiving of materials. Performs other duties as required in support of department, functional and company goals.

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.

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 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.

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.

FUJIFILM Diosynth Biotechnologies is searching for a junior or senior Automation engineer to support Bioprocess operations at their NC site.  The primary purpose of this position is to provide diagnostics/troubleshooting support for the manufacturing, development, and facilities process control and monitoring systems with some focus on implementing new process automation technology in Bioprocessing industry.

Summary: The Microbiology Analyst I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. 

Summary:  The Information Technology Lab Engineer serves as the IT support for Quality and/or Laboratory Information Systems.

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. 

Summary: The Quality Control Stability Coordinator will be responsible for carrying out supporting activities on the stability program according to current regulations.  This includes working with Clients to draft stability protocols, physically setting up stability studies according to respective stability protocols (staging), updating and maintaining stability planning/scheduling tools, ensuring timely execution of stability pulls at each time point, ensuring timely execution of in-house or external testing, writing summary reports, and ensuring the timely delivery of customer-oriented data and documentation.

Summary:  The Quality Control Compliance Manager leads the tracking, coordination, and closure of Quality Control’s CAPAs, change controls and deviations.  The successful candidate will also assist the QC department in OOS/OOT investigations.  The candidate will ensure all PRs and change controls are closed out in a timely manner.   

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.