The Specialist, Quality Control (QC) Sample Management is responsible for handling samples manufactured at the site, sample and reference materials from outside sources (e.g., drug products), and stability samples. This role ensures sample transactions are documented by performing entries into electronic systems (LIMS and FreezerPro) or via forms outlined in the sample handling standard operating procedures (SOPs). Additionally, this role handles sample shipments according to stability protocols or shipping form instructions, supports continuous improvement projects, and provides input into the sample handling process.

The Manager, Supplier Quality and Material Control ensures supplied materials meet company standards through a combination of auditing suppliers’ quality systems, inspecting, and analyzes quality data, and collaborative problem-solving with suppliers and internal teams to resolve issues while implementing continuous improvement initiatives. The Manager is responsible for the inspection and release of all Good Manufacturing Practice (GMP) consumables, raw materials, and labeling manufactured product, in addition to the release of manufacturing utilities, rooms, and equipment used in manufacturing processes and maintenance of the QA retention program. This role interacts with regulatory agencies during compliance inspections, manages supplier change...

The Senior Manager, Quality Assurance (QA) Technical provides technical leadership and oversight for QA in a regulated pharmaceutical environment. This role reviews and approving Good Manufacturing Practice (GMP) documentation (e.g., batch records), leads investigations and root cause analyses for deviations, corrective and preventive actions (CAPAs), manages change controls, and ensures compliance with quality and CGMP regulations. This role also supports validation, automation, data integrity, environmental reports and facility reports while collaborating with internal stakeholders and clients on clinical and GMP events.

The Process Mechanic 2 is responsible to perform general to moderate mechanical repairs to plant equipment and systems. This role performs routine mechanical troubleshooting and preventative maintenance tasks. Additionally, this role ensures systems meet stringent requirements of pharmaceutical manufacturing.

The Production Technician 4 leads and executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

The Production Technician 3 executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP) quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

The Quality Assurance (QA) Disposition Manager is responsible for the disposition of both clinical and commercial manufactured products (intermediates and Active Pharmaceutical Ingredients (APIs)) ensuring products are produced and analyzed in accordance with FUJIFILM Biotechnologies procedures and Current Good Manufacturing Practice (CGMP) regulations while making recommendations as needed to release or reject manufactured materials that are manufactured at the site. This role organizes, maintains, and communicates the status of batch disposition details, and partners cross-functionally, including with external stakeholders to meet the dynamic needs of the customers programs.

The Supply Chain Coordinator 2 develops and maintains integrated production planning and scheduling that encompasses materials to ensure that supply targets are met. This position is responsible for ordering and buying materials as well as tracking production and material consumption in the applicable systems.

The Supervisor, Financial Accounting role at FLB is a critical position that oversees the company’s accounting functions, ensuring compliance with generally accepted accounting principles, company policies and financial management practices specific to the contract manufacturing industry. This role demands exceptional organizational abilities, a strong technical accounting background and outstanding communication skills. This role effectively manages multiple projects and assignments with competing deadlines.

The Senior Inventory Specialist maintains inventory spares for the repair and maintenance of processing and utility equipment used at the facility. This role maintains inventory stocking levels to support plant changeover processes, documents issuance and receipt of materials within the Computerized Maintenance Management System (CMMS) to support client charges and remains up to date on industry practices for inventory control.

The Associate 1, Quality Control (QC) Microbiology is an entry level position responsible for performing routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support activities and participates in continuous improvement initiatives.

The Production Technician 4 leads and executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

The Production Technician 3 executes manufacturing processing steps and associated activities while maintaining strict adherence to quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

The Process Mechanic 3 is responsible to perform general to advanced mechanical repairs to plant equipment and systems. This role performs routine mechanical troubleshooting and preventative maintenance tasks. Additionally, this role ensures systems meet stringent requirements of pharmaceutical manufacturing.

The Manufacturing Lead (Downstream) oversees and performs Current Good Manufacturing Practice (CGMP) manufacturing operations for manufactured biopharmaceutical products. This role ensures the effective use of material, equipment, and personnel while making products at high-quality levels. Additionally, this role is recognized as a subject matter lead regarding manufacturing processes and leads more junior members of the shift through manufacturing processes.

The Manufacturing Lead (Upstream) oversees and performs Current Good Manufacturing Practice (CGMP) manufacturing operations for manufactured biopharmaceutical products. This role ensures the effective use of material, equipment, and personnel while making products at high-quality levels. Additionally, this role is recognized as a subject matter lead regarding manufacturing processes and leads more junior members of the shift through manufacturing processes.

We’re searching for a dynamic, high-energy, and hard-hitting Chief of Staff to the CFO of FUJIFILM Biotechnologies.  Reporting directly to the CFO and regularly interacting with other leaders and company executives, the Chief of Staff to the CFO will provide independent judgement and a commitment to excellence to drive company strategy and performance. The ideal candidate will have proven success in a dynamic and fast-paced business environment, with a special focus on executive-level advising and ensuring strong intradepartmental collaboration.  

The Director, Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies North Carolina sites, and globally, as needed. This role serves as the subject matter expert (SME) for regulatory practices and procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists through fostering a culture of growth and development in alignment to organizational goals while collaborating cross-functionally to drive continuous improvement and optimize Regulatory approaches.  

The Associate Manager of Manufacturing leads daily manufacturing operations during a 12-hour shift. This position is responsible for managing a cross-functional team of technicians executing cell culture and microbial fermentation processes using both single-use technologies and stainless steel, ensuring compliance and efficiency in a fast-paced, modular multiproduct environment. This role has direct impact on the delivery of manufacturing focused site key performance indicators (KPIs). Additionally, this role incorporates prior hands-on bioprocessing experience, thrives in a regulated and client-facing environment, and demonstrates operational leadership and mentorship across varying...

The Associate 2, Quality Control (QC) Microbiology is responsible for performing routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support activities and actively participates in continuous improvement initiatives. 2nd shift.