The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators.

The Scientist 2, QC Chemistry is a technical subject matter expert (SME) responsible for QC analytical chemistry methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Scientist 2, QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs...

The Sr. Analyst 1, QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based analytical 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). This role supports the transfer and validation of methods such as residuals (HCP, DNA, Protein A), dot blot for product identity, ELISA ID/ Potency and various cell-based assays. The Sr. Analyst 1, QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and...

As an upstream supervisor, you’ll lead and inspire a team of manufacturingassociates, supporting the start up of a new large scale cell culture facility. The Upstream area includes: An...

The Production Scheduler, Drug Product Finished Goods is responsible for creating, maintaining, and optimizing daily and long-term production schedules across drug product manufacturing, filling, inspection, and packaging operations. This role ensures timely product delivery and efficient use of resources while adhering to current Good Manufacturing Practices (cGMP). Acting as a central coordination point, the scheduler partners with other departments

The Project Manager 2 is responsible for collaborating with internal and external stakeholders, including but not limited to Environmental, Health & Safety(EHS), Maintenance, contractors, vendors, and clients. This role is responsible to handle administrative aspects of the project from start to completion, track and monitor the project status and milestones, and ensure projects meets all standards, timelines, and budgets.

Utility Maintenance 2 performs corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs), completes work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. The corresponding utilities include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water.

Act as the local Compliance Officer for both of FUJIFILM Biotechnologies sites in North Carolina region.  In addition, they will be the main Compliance contact / support for any questions / requirements for FUJIFILM Biotechnologies.

Business Technology & Digital Solutions is a fast-growing organization responsible for driving the digital transformation at FUJIFILM Biotechnologies. You will be surrounded by highly dedicated and skilled colleagues worldwide, all working together to ensure stable, efficient, and compliant IT solutions. The...

The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and on-time commercial production. This role provides technical expertise to the immediate team and other stakeholders, as needed. Additionally, this role leads a team of Engineers and provides coaching and direction.

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation

The Automation Engineer 3, DSM Downstream will provide support to the Drug Substance Manufacturing (DSM) 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 focuses on supporting the delivery of DeltaV logic for Downstream process areas including Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing. 

The Automation Engineer 2, 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 Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate Director collaborates with...

The Process Analyst is tasked with analyzing, documenting, and performing gap analysis on finance processes across six sites within the group. This position supports project managers in finance transformation projects and exists to optimize workflow efficiency, enhance cross-functional collaboration, and identify and assess alignment of existing processes. Engaging with various departments, the Process Analyst facilitates sessions for process mapping and optimization, establishes and maintains governance structures, ensuring a cohesive future approach across the organization.

The Finance Transformation Project Manager plays a pivotal role in managing and executing finance-specific projects within Fujifilm Biotechnologies. This role involves overseeing complex, strategic financial change initiatives and process improvements that contribute to the success Fujifilm Biotechnologies, readying the business for 4x revenue growth by FY30. The incumbent will ensure efficient budget management, deliverable tracking, and financial system enhancements crucial for achieving long-term business objectives.

The work we do at FUJIFILM Biotechnologies (FB) has never been more important and we are looking for talented candidates to join us. We’re growing our capabilities and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive.  This is what FDB...

The Senior Director of Operations Excellence will be a key leader in Fujifilm Biotechnologies across several areas of the business. The role will be responsible for identifying, planning, and driving improvements across all sites in the business. These improvements will include, but not be limited to, productivity increases, costs savings, revenue increases, and systemic process changes. The role will also have a significant hand in shaping the strategy of the Operations Excellence (OpsExc) team and its agenda for the next 2-3 years.   The ideal candidate...

Utility Maintenance 3 will perform corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs). Complete work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. Utilities to include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water.

This role will perform 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.