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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.
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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 Senior Customer Sourcing Specialist is responsible for customer onboarding activities, coordinating material enrollment, supporting tech transfer, and
sourcing activities for customer programs at FDBN. Support of the Denmark facility, as needed. This role is a key link between the global sourcing
organization and customer program organization for matters related to risk assessment of materials, vendors, new materials, and vendor onboarding
activities. This role is responsible to conduct sourcing-related deliverables linked to both new and existing customer programs, with aggressive timelines.
This role is also responsible to build relationships with cross-functional stakeholders, communicate effectively, and define details to navigate through...
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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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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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The Internal Communications Specialist provides communication support and direction for strategic initiatives and operational topics. This position supports and maintains FDB’s global standards and develops editorial and video content for intranet, publications newsletters, e-boards, presentations and other internal communication channels. This role works closely with members of the FUJIFILM Biotechnologies Communications Team and supports communications for the Morrisville location.
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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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Join a high-impact Quality Control team where you’ll own the lifecycle of critical analytical instruments that keep life-changing therapies moving. As Sr. Specialist 2, QC Instrumentation, you will lead the routine operation, qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation with minimal supervision—while ensuring data integrity and regulatory compliance at every step.
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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.
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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 monitoring mechanical and electrical equipment, power distribution, chilled water, process gas, domestic and de-ionized water, water for injection (WFI), clean steam generator and distribution, plant steam boilers,...
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The Automation Engineer 2, BMS/VDS provides support for the sitewide Building Management System (BMS) and Validated Data System (VDS). This includes implementation of changes to the utility and facility automation systems, updating design documents, executing testing, troubleshooting events, and providing on-call support. This role participates in and may lead projects and medium- to complex-level changes while coordinating with internal and external...
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Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 3 to lead and execute manufacturing processing activities in a cGMP environment. You will support project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facility—helping ensure safe, consistent, and efficient production of drug substance. This role requires flexibility with working hours and shift rotations.
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Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 3 to lead and execute manufacturing processing activities in a cGMP environment. You will support project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facility—helping ensure safe, consistent, and efficient production of drug substance. This role requires flexibility with working hours and shift rotations.
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The Manager, Process Engineering is responsiblefor leading the Upstream and Downstream Drug Substance Manufacturing (DSM) Process Engineering team and activities from inoculation through bulk fill. The Manager utilizestheir technical expertise with process...
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The Senior, QC Microbiology supports t QC, detecting, and mitigating microbial contamination across facilities, utilities, processes, and products. The roleapplies microbiology principles to validate sterilization, aseptic processing, and cleaning/sanitization; executes environmental and utility monitoring; and ensures compliance with FDA, EU, and global regulatory requirements. This position leads complex testing and data analysis, investigates contamination events and deviations, and partners cross-functionally (Manufacturing, MSAT/Engineering, QA/QC, EHS) to maintain product quality and patient safety. This...
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Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 4 to lead and execute manufacturing processing activities in a cGMP environment. In this senior role, you will support both project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facility—helping ensure safe, consistent, and efficient production of drug substance. You will also assist with daily scheduling and materials oversight for the manufacturing team.