The Customer Sourcing Specialist is responsible for customer onboarding activities, coordinating material enrollment, supporting tech transfer, and sourcing activities for customer programs at FDBN. Support of the Denmark facility, as needed. This role is a key link between the global sourcing organization and customer program organization for matters related to risk assessment of materials, vendors, new materials, and vendor onboarding activities. This role is responsible to conduct sourcing related deliverables linked to both new and existing customer programs, with aggressive timelines. This role is also responsible to build relationships with cross-functional stakeholders, communicate effectively, and define details to navigate through challenges. The Customer Sourcing Specialist will be working cross functionally in an external capacity with customers and suppliers, but also internally with Manufacturing, Process Science, Quality, Supply Chain Planning, Finance, and FDBD Denmark team.

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

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. 

The Manufacturing Support Associate 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.   

The Manufacturing Specialist 2, MES & DCS performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to DeltaV Distributed Control Systems (DCS) and Manufacturing Execution System (MES). The manufacturing facility will be 24/7 operational and the role may require flexibility with working hours and shift rotation.

The Manufacturing Specialist 2, SAP performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to Systems, Applications, and Products in Data Processing (SAP) material transactions. This manufacturing facility will be 24/7 operational and the role may require flexibility with working days and/or nights and shift rotation.

The Automation Engineer 3, DSM CIP & Clean Utilities, will support the Drug Substance Manufacturing (DSM) facility. This includes implementing changes to the automation systems, updating design documents, executing testing, troubleshooting events, and being a part of on-call automation support.

In the project phase, your main responsibility as the Automation Engineer 3, DSM CIP & Clean Utilities will be to provide Engineering input on the design and implementation of an Emerson DeltaV control system in the areas of Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system for the defined process areas. 

The Sr Automation Engineer 1, DSM DeltaV Infrastructure will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.

The IT Support Analyst 3 is responsible for all first level IT support to internal stakeholders (e.g., troubleshooting of incidents, escalation based on incident management procedures, handling of IT requests and user administration). This role helps to establish the IT Service Desk and participates in projects within IT. The IT Support Analyst 3 drives excellent service delivery and processes within IT, while collaborating with other FDB sites domestically and globally to ensure alignment across key areas

The Manager, QC Laboratory Information Management System (LIMS) is responsible for developing strategic plans for implementing FDB's global Laboratory Information Management System (LIMS). This role harmonizes processes across all current and future FDB sites and leads the transition of QC into a paperless environment. The Manager, QC LIMS guides a team of LIMS experts to translate global and site-specific needs into user requirements, system design, configuration, and implementation plans. This role acts as the primary subject matter expert (SME) for LIMS and focuses on maintaining and continuously enhancing the global LIMS system.

The Senior Financial Business Partner provides strategic financial support to the business. This position requires a blend of financial expertise, business acumen and the ability to influence and drive strategic initiatives. This role acts as a key advisor to the Program Management leadership, supporting all financial elements relating to revenue recognition accounting, contract review and approval and sales to program margin forecasting. This role is also responsible for ensuring financial goals are met and business strategies are effectively implemented. The role involves engaging with business partners to understand business processes, performance, highlighting risks and opportunities, and fostering well-informed decisions.

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams.   

These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational. We will have a day shift and a night shift. We are hiring for night-specific roles; however, all roles may require flexibility with working hours and/or shift.

We operate on a 2-2-3, 12 hour shift schedule (days or nights).

*** Please note that this posting represents multiple openings *** 

The Senior Automation Engineer 1, MES provides support to the Drug Product Finished Goods Manufacturing (DPFG) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role leads projects and handle complex changes while coordinating with other internal and external groups.

The Supervisor, Quality Assurance Operations is responsible for providing supervision and risk-based QA support for the Drug Substance Manufacturing areas and processes.

The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 

The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization to drive continuous improvements within the team. As member of the site Quality leadership team contribute to cohesive execution of quality initiatives and projects throughout the site in Holly Springs.

The Scientist 1, QC Analytical Development Chemistry supportsthe transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth, Holly Springs (FDBN). The Scientist 1, QCAD ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. The Scientist 1, authors transfer documents and executestesting as part of transfer for the following analytical methods: HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary  electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF)); general pharmaceutical properties methods.

The Vice President (VP) of Quality Assurance (QA) is a senior leader overseeing QA functions at our Holly Springs site. This pivotal role ensures compliance with regulatory standards, drives quality initiatives, and safeguards product and process integrity. Responsibilities include strategic planning, team leadership, and cross-department collaboration to promote quality excellence.

You will develop and implement the QA strategy for Holly Springs, working closely with the site Head and global leaders to ensure consistency. A key aspect of this role is overseeing the integration and adherence to the FDB quality system, ensuring robust operational standards. This position is also accountable for delivering quality programs and projects, ensuring staff engagement, and aligning execution with customer expectations, regulatory standards, and industry best practices.

As Vice President of QA, you are also a key member of the leadership team in Global QA Operations, playing an integral role in guiding global quality strategies. A significant responsibility includes participating in the development of the global QA strategy to enhance innovative, cross-corporate streamlined quality processes. This role will have approximately 5-10 direct reports and approximately 15-30 indirect reports.

The Sr Automation Engineer 1, DSM CIP & Clean Utilities, will support the Drug Substance Manufacturing (DSM) facility. This includes implementing changes to the automation systems, updating design documents, executing testing, troubleshooting events, and being a part of on-call automation support.

In the project phase, your main responsibility will be to provide Engineering input on the design and implementation of an Emerson DeltaV control system in the areas of Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system for the defined process areas.