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The Spare Parts Associate organizes and maintains the inventory of spare parts for the site. This role assists with submitting orders to replenish inventory,
enters new inventory within the computerized maintenance management system (CMMS) and prepares parts for work execution.
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The Process Engineer 2 that supports Drug Product Finished Goods (DPFG) within the assigned area(s) [Visual Inspection] provides engineering guidance to stakeholders throughout the organization to support capital projects, technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, compliant with Current Good Manufacturing Practice (CGMP) regulations. This role adheres to product and customer requirements and works toward optimizing plant efficiency and reliability. This role also utilizes their experience with automated systems related to inspection of pharmaceutical products and camera and vision-based inspection...
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Help power life-changing biologics by orchestrating the heartbeat of our Drug Substance Manufacturing (DSM) operations. As the Production Scheduler, you’ll own the daily and long-term production schedule, drive schedule adherence, and coordinate activities across Maintenance, MSAT (Manufacturing Science and Technology), Engineering, Quality, Supply Chain, and more—keeping people, materials, and equipment moving in sync.
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The Manufacturing Science and Technology (MSAT) Engineer 3 provides technical leadership across current good manufacturing practice (cGMP) manufacturing, delivering end-to-end support for scale-up, process validation, continued process verification, and continuous improvement. This role drives technology transfer (TT) of new and existing drug product processes into and between sites, ensuring robust process fit, compliant documentation, and readiness...
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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.
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The Associate Director of Accounting oversees accounting operations across our North Carolina region, ensuring accurate financial reporting, strong internal controls, and compliance with GAAP/IFRS and company policies. This role partners with our global leadership and cross-functional teams to drive operational excellence, support strategic decision-making, ensure our house-in-order and lead a high-performing accounting team. Responsibilities include monthly close management, audit readiness, process optimization, and leveraging systems to enhance efficiency and data integrity. This role requires a strong internal control mindset and a highly driven individual with managerial...
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Help build and sustain reliable, compliant manufacturing at a world‑class, 24/7 biomanufacturing site. As a Manufacturing Specialist I, Materials, you will be a key driver of operational readiness, daily production excellence, and continuous improvement. This role supports a round‑the‑clock...
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The Automation Engineer 3, DSM PI Data Historian, 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.
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Oversee leave of absence programs to include FMLA; ADA; Pregnancy Worker’s Act; other federal, state, or local-mandated leave; and company leave. Provide operational oversight of third party leave vendor. Administer accommodations programs. Serve as a resource and subject matter expert (SME) on leave management consistent with local, state and federal regulations.
The work location for this exciting opportunity is Holly Springs, NC and will support FLB’s Holly Springs and Morrisville locations.
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Join a high-impact team that keeps life-changing biopharmaceutical manufacturing running smoothly. As a Material Handler, you’ll be the engine behind safe, compliant, and efficient material flow across GMP cleanroom environments—ensuring production teams have exactly what they need, when they need it. If you thrive in a fast-paced, highly regulated setting and take pride in precision, this is your moment.
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Drive operational excellence across our manufacturing network. In this role, you’ll lead our Continuous Improvement (CI) and 5S programs—governing intake, review, monitoring, and reporting of CI initiatives while delivering hands-on training and coaching to manufacturing teams. You will champion 5S education (sort, straighten, standardize, sustain) across all factories to build a culture of safety, quality, and efficiency.
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The I&C Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with instrumentation and automation systems and controls across the campus. The I&C Engineer provides support for the metrology department through evaluations of instrument deficiencies, test equipment issues and calibration strategies and methods. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and...
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The tech transfer role (drug product) includes the management and coordination of activities for products transferred into large scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This involves managing between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology.
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The Lead Warehouse Associate position is responsible for storage, handling, and distribution of materials and products. This role leads and supports the
Warehouse operations team in receiving, shipping, and/or logistics. The Lead Warehouse Associate works closely with multiple areas to support
operations (e.g., Manufacturing, Quality, Process Sciences, and other customers) as needed. This role uses SAP ERP system for inventory management,
cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs). This position requires shift work and
weekend hours to support operations and is required to...
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The Analyst, QC Microbiology is responsible for the key operational aspects of the QC Microbiology laboratory. This role performs microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples under minimal supervision. The Analyst, QC Microbiology is responsible for all activities associated with testing in accordance with written procedures. This role participates in writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff, as needed and in addition to regular work duties and assignments.
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This is a night shift position supporting our 2/2/3 schedule from 6pm-6am.
The Utility Operator 2 operates, maintains, and repairs black and clean utility systems. This position is also responsible for...
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Make a direct impact bringing lifesaving therapies from partner sites to GMP manufacturing. As a Manufacturing Specialist – Tech Transfer, you will lead and execute end-to-end drug substance tech transfers from external partners/CMOs into our site, coordinating cross-functional activities, ensuring process and documentation readiness, supporting scale-up and validation (PPQ), and enabling efficient, compliant start-up of commercial or clinical production.
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The Planner 2, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role uses knowledge of maintenance processes and regulatory requirements to plan, schedule, and coordinate maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role seeks opportunities for continuous improvement and collaborates cross-functionally to ensure successful completion of maintenance activities.
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The Supply Chain Compliance Specialist 2, is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support includes initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions to prevent recurrence and drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and...
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The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.