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The Manufacturing Lead executes and leads manufacturing processing steps, associated activities, and assists the supervisor/manager, as needed. The Lead adheres to and helps ensures all activities performed within the designed shift comply with Current Good Manufacturing Practice (CGMP) and other safety or quality standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.
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The Quality Control group at FDBU group is seeking a Lead QC Associate II to support a broad range of analytical disciplines within the Quality Control laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. Analytical disciplines common to the laboratory include, but are not limited to: Chromatography, HPLC, Concentration determination, pH, Total Organic Carbon, Gel based protein separation, IEF, Plate Based Assay, and conductivity.
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The QC LIMS Developer designs, configures, validates, and supports Laboratory Information Management System (LIMS) capabilities for Quality Control laboratories. This role builds compliant digital workflows for sample lifecycle, stability, specifications, CoAs, instrument/data integrations, and reporting, ensuring data integrity, GMP compliance, and on-time product/material release.
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The Lead Associate 3, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively trains junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.
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The Supervisor, QC Microbiology leads a team of microbiology analysts to execute GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing. This role ensures cGMP compliance, data integrity, safety, and right first-time performance, while driving method robustness, investigation quality, and continuous improvement. The Supervisor typically supervises staff and junior scientists, manages day-to-day operations, and contributes to cross functional initiatives of moderate complexity.
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The Quality Control group at FDBU group is seeking a Lead QC Associate II – Raw Materials at our Bioprocess Innovation Center in Morrisville, NC. The QC Lead Associate II is responsible for sampling, testing, and releasing incoming raw materials in compliance with GMP, regulatory standards (USP/EP/JP), and internal quality procedures. This role ensures materials meet specifications prior to use in manufacturing and supports data integrity, documentation, and continuous improvement within the Quality Control laboratory.
Shift: Monday – Friday...
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Design the security backbone that protects science, patients, and clients across FUJIFILM Biotechnologies. As our Global Solution Architect (IS&O) for Enterprise Security, you will translate complex business and technical needs into scalable, secure architectures—elevating delivery quality, accelerating outcomes, and ensuring alignment with enterprise, infrastructure, and compliance standards worldwide. Your work will reduce risk, prevent rework, and enable confident, compliant growth across our global network.
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Join a high-growth, transformation-stage global CDMO shaping the future of biologics and advanced therapies. As Senior Director, Global Sourcing & Procurement, you will architect and scale a world-class procurement function that powers tech transfers, new product introductions, and reliable cGMP/GxP-compliant supply for clients worldwide. Reporting to the SVP, Global Supply Chain, you will set the strategy, build the team, and deliver measurable enterprise value across quality, cost, speed, sustainability, and risk. We are a global CDMO in a strong growth and transformation phase, committed to advancing therapies with uncompromising quality, compliance, and reliability. Our culture values...
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The Weigh and Dispense Supervisor is primarily responsible for the day-to-day oversight of the Weigh and Dispense team. Key responsibilities are scheduling, preparation and kitting of consumable and raw materials for cGMP process execution in Manufacturing in a cGMP environment. This role involves interaction with Quality, Manufacturing, Warehouse, Supply Planning, and Asset Planning to ensure successful operations. The Supervisor is required to work standard business hours, and must support on-call duties and emergency responses to maintain operational success.
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The Senior Manager, Compliance Manufacturing will lead the design, execution, and continuous improvement of the company’s compliance program. Oversee risk assessments, policies and controls, monitoring and testing, investigations, training, reporting, and regulatory engagement. Manage a team of compliance professionals and partner with business leaders to embed a culture of compliance and ethical conduct.
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The Weigh and Dispense Associate III is primarily responsible for the preparation and kitting of consumable and raw materials for cGMP process execution in Manufacturing. This role involves interaction with Quality, Manufacturing, Warehouse, Supply Planning, and Asset Planning to ensure successful operations. Responsibilities include weighing and dispensing materials, delivering goods to manufacturing, and handling return reconciliation when necessary. The Associate is required to work standard business hours, with potential for on-call duties and emergency response to maintain operational success.
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The QA Technical Specialist II performs final disposition of GMP raw materials and consumables to ensure timely availability for manufacturing. Serving as the QA point of contact for Warehouse, Supply Chain, and QC Raw Materials, this role resolves material-related issues and escalations, conducts quality impact assessments for investigations, change controls, and supplier change notifications, and ensures compliance with applicable procedures and data integrity requirements.
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The Supply Chain Coordinator II 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 system and tools.
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Investigator 2, Manufacturing is responsible to perform investigation for Cell Culture, Fermentation and Downstream programs to identify impact for events/minor/major and close PRs within the required standard work timeframe. This role contributes to the creation of effective corrective
and preventative actions (CAPA’s) while ensuring timely closure of assigned investigations.
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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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The QA Operations Specialist is responsible for providing quality oversight of the day-to-day manufacturing operations for Drug Substance Manufacturing. This is primarily achieved through record and data review, area inspection, and incident resolution.
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The successful Scientist II monitors ongoing experiments, identifies or resolves complex technical project issues, and provides technical leadership within the group. The individual takes a more active role in non-routine process development activities and may act as a technical lead for the analytical component of client programs.
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This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing
facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
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The Senior FinancialBusiness Partner providesstrategic financial support to the business. This position requires a blend of financial expertise, business acumen and the ability to influence and drive strategic initiatives. This role acts as a key advisor to the Program Management leadership,...
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The SeniorAccountant, Audit Readiness& Operationsis responsible for managingthe financial close processand audit engagements (external, internal, and SOX), driving operational accounting excellence, and strengthening the company’s control environment. This role owns the company’s audit readiness posture—