The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).

We are seeking a hands-on, impact-driven DP MSAT Senior Engineer 1 to accelerate our path to operational readiness in a dynamic, start-up environment. This role will lead drug product technical activities from day one, with a primary focus on standing up processes, resolving start-up issues, and supporting client tech transfers into our facility. The ideal candidate brings deep experience in end-to-end tech transfer execution and on-the-floor troubleshooting, with strong competency in automated visual inspection (including recipe creation and qualification), container closure integrity testing (CCIT) qualification, aseptic process simulations (APS/media fills), and filling isolator...

This role as manufacturing Associate 4 will execute manufacturing processing steps and associated activities. This position will also support and assist in scheduling daily manufacturing activities for the team.    This role operates on a 2-2-3 schedule for Night Shift- 6P-6A.

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required.    This role operates on a 2-2-3 schedule for Night Shift- 6P-6A.

The Investigator 1/2 performs minor investigations, identifies root and contributing causes, and contributes to the creation of effective corrective and preventive actions (CAPAs) while ensuring timely closure of assigned investigations. This role also supports senior investigators with major investigations and other tasks, as needed.

This role as manufacturing Associate 4 will execute manufacturing processing steps and associated activities. This position will also support and assist in scheduling daily manufacturing activities for the team.    This role operates on a 2-2-3 schedule for Day Shift- 6A-6P.

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required.    This role operates on a 2-2-3 schedule for Night Shift- 6P-6A.

This role will lead and execute manufacturing processing steps and associated activities.    This role operates on a 2-2-3 schedule for Day Shift- 6A-6P.

This role will lead and execute manufacturing processing steps and associated activities.     This role operates on a 2-2-3 schedule for Night Shift- 6P-6A.

The Digital Operations Specialist 1 is an early-career professional responsible for deploying, configuring, and sustaining digital manufacturing systems (e.g.,Manufacturing Execution Systems (MES), data historians, electronic logbooks) in a current good manufacturing practices (cGMP) environment. This role performs work of moderate scope with increasing independence, contributes to recipe-driven operations and electronic batch execution for drug substance

The QC Specialist, Instrumentation works under the direction of senior team members to support routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role helps ensure compliance with Data Integrity standards, following regulatory guidelines and company procedures. The Specialist assists with routine maintenance, conducts periodic reviews of QC analytical instruments, and helps identify and address deviations or issues. The position also involves providing support for on-call and weekend coverage when needed.

The Supervisor, Drug Product Filling supports start up and operational activities for the site. This role leads a shift team and is responsible for the manufacturing process and facility which will eventually operate 24/7 model.

The Senior Automation Engineer 1, MES, provides support to the DPFG facility. This includes implementing changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being part of Automation on-call support. This role will lead projects and handle complex changes while coordinating with other internal and external groups.

The Manager of Programmable Logic Controller (PLC) is responsible for overseeing the implementation and maintenance of PLC systems throughout the facility, including standalone PLC control systems, building management systems (BMS), computer system validation (CSV), and validated environmental monitoring systems. This role supports the management of automation projects, ensures compliance with regulatory requirements, and contributes to the continuous improvement of automated processes. Additionally, this role collaborates cross-functionally to enhance production efficiency and quality through automation technologies while leading and developing a team of engineers.

The Manager, Digital Technologies will be responsible for managing the QA Digital Technologies team, including Quality oversight of IT and Automation (OT) systems through to operational readiness, as well as oversight of the execution of the computer system validation program for these systems. This role will collaborate within the Digital Technologies (DT) Quality team, as well as with other project teams and QA departments at other FLB sites, with a focus on consistent policy administration, QA oversight of day-to-day...

The QA Specialist, Warehouse (Supply Chain) is responsible for partnering in the Quality oversight of the Warehouse and Supply Chain area at FLBN. This role provides oversight of applicable processes and systems in both Warehouse (WH) and Supply Chain (SC) areas, with a focus on Quality attributes of the process. The QA Specialist ensures QA oversight of day-to-day activities and provides relevant QA input on the resolution or mitigation of operational issues as needed.

The Supervisor for Electrical & HVAC is responsible for overseeing and coordinating the operations of critical systems while leading and developing a team of technicians. This role focuses on ensuring adherence to environmental, health, and safety (EHS), Good Manufacturing Practice (GMP), and other regulatory standards, providing training, technical support, and leadership to the team, and actively seeks opportunities improvements for electrical distribution and HVAC systems.

The Manager, All-QC team is responsible for contributing to key functional, tactical, and operational aspects of the QC group and will lead the 223-shift teams that are responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all the QC laboratories required for urgent testing/Manufacturing support. This role will direct the scheduling across all shifts, initiation of process improvements, serve as a liaison across all QC teams, modeling the leadership competencies, aiding in the development of peers and performing QC approvals, as...

The Utility Operations Coordinator supports the day-to-day execution activities within the assigned function (e.g., Maintenance, Instrumentation & Controls, Utility Operations, etc.) by facilitating work order readiness, ensuring tool and material availability, managing technician workflow, and serving as a liaison between maintenance, production, quality, and other support teams to maintain optimal equipment performance with minimal downtime. This role provides input to maintenance protocols, participates in cross-functional initiatives that drive organizational efficiency, and ensures compliance with Current Good Manufacturing Practice (CGMP), safety, and company procedures. Additionally,...

The Manufacturing Support Associate 2 provides reliable support to the Drug Product Manufacturing operation during the establishment of the facility and processes. This position supports the creation of standard operating procedures, processes, trainings and documentation along with supporting tech transfer, batch planning, documentation updates and coordination of non‐batch activities including changeover, PMs, deviation management and audit