The Automation Engineer 1, Building Management System (BMS) provides support to the entire facility ensuring efficiency and reliability of the automated systems that monitor and control environmental conditions and utility production. This role supports senior engineers with the implementation of changes to the automation systems, execution of testing and troubleshooting events, and provides on-call support, as needed. Initially, this role supports the expansion project for the facility with the scope evolving as the project progresses. 

The Supervisor of Utility Operations is responsible for overseeing and coordinating the operations of utility systems and the team of utility operators to ensure smooth and efficient operations. This role focuses on maintaining and managing equipment, vendors, and daily operational activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practices (GMP) standards. Additionally, this role also provides training, technical support, and leadership to the utility operations team.

The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. 

The Weigh and Dispense Associate position is responsible with assisting and executing in the set-up, and weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role will interact with manufacturing personnel in both Drug Substance and Drug Product teams as well as Warehouse for commercial operations and tech transfer activities required from the Weigh and Dispense operations. This role will be responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed.  

The Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.

The Production Scheduler, Drug Substance Manufacturing (DSM) is responsible for creating, maintaining, and optimizing daily and long-term production schedules across DSM operations. This role ensures timely production 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 (e.g., Manufacturing, Planning, Maintenance,

The Associate Investigator assists with and performs minor investigations, root cause analyses, and collaborates cross-functionally. This role ensures the assigned investigations are completed timely and provides support to senior investigators, as needed.

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 Manufacturing Specialist 1, 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 Sr. Strategic Planner 1 role will be responsible for driving the Sales & Operations Planning at FLBN, Holly Springs site. This role will integrate commercial sales forecast with production planning, inventory strategy, and capacity for both Drug Substance and Drug Product/Finished Goods. This role will be a key liaison for strategic planning at the Holly Springs site between clients, production, and Site Leadership. This role will drive the Sales and Operational

The Director, Drug Substance Manufacturing (DSM) plays a critical role in the design, execution, and leadership of DSM Operations strategy for the Holly Springs site. This role is accountable for all upstream and downstream manufacturing operations, ensuring safe, compliant, and successful delivery of life changing therapies for patients. The Director, DSM guides leaders, develops high-performing teams, and works cross-functionally to ensure alignment with our global network, including our partner site in Denmark. This role...

The Senior Human Resources Business Partner 1 plays a vital role in ensuring employee satisfaction, engagement and retention through the collaboration and strategic relationships built among employees and management. This role is a strategic business partner who “leans in” to ensure the needs of the business are met, along with the consistent implementation of policies and practices. The HR Business Partner is a leader who shows empathy with appropriate firmness while driving HR programs that focus on our people. This is a highly visible role that also coaches and mentors fellow HR employees.

The Sr. Analyst 1, QC Analytical Development (AD) Chemistry works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Sr. Analyst 1, QC AD Chemistry adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes...

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...

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

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 Senior Supply Chain Analyst role supports Supply Planning and Warehouse. Using both soft and technical skills, the analyst role works cross functionally with other areas (e.g., Manufacturing, Quality, and Process Science) to analyze data for future improvement and cost analysis. This role is both tactical and transformational by initiating, preparing and facilitating initiatives to build a strong Supply Chain for the future. The Senior Supply Chain Analyst contributes to establishing KPls and ensures transparent, unambiguous visual and verbal communication to drive optimization of stock levels for both cost and availability to support warehouse and production capacity.

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 Global Lead, Data Architecture & Platforms (internally known as the Director, Data Architecture & Platforms) is responsible for defining and governing the enterprise data architecture, ensuring robust data management, governance, and excellence across the biotechnology value chain. The role ensures that data platforms are designed and...