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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 Senior Project Manager, Strategy & Execution leads high-impact, cross-functional projects and strategic initiatives that advance the site’s operational and business strategy. This role sets the standard for project management excellence and cross-functional collaboration, translating strategy into executable roadmaps, establishing governance and delivery discipline, and ensuring benefits realization. The position partners closely with Site Leadership and functional leaders (Operations, Quality, EHS, Supply Chain, Finance, IT, HR) to prioritize, plan, and deliver...
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The Senior Project Manager, Strategy & Execution leads high-impact, cross-functional projects and strategic initiatives that advance the site’s operational and business strategy. This role sets the standard for project management excellence and cross-functional collaboration, translating strategy into executable roadmaps, establishing governance and delivery discipline, and ensuring benefits realization. The position partners closely with Site Leadership and functional leaders (Operations, Quality, EHS, Supply Chain, Finance, IT, HR) to prioritize, plan, and deliver...
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Build life-changing medicines with a team that trusts you to lead on the manufacturing floor. As a Manufacturing Associate 3 (Drug Substance Manufacturing), you’ll take ownership of critical processing steps, help bring new capacity online, and keep a 24/7 operation running safely, compliantly, and on time. If you thrive in hands-on, fast-paced environments and enjoy guiding others, this is your next step.
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Help deliver safe, high-quality medicines at scale. As a Manufacturing Associate 3, Drug Product, you’ll play a hands-on role in component/parts preparation, thawing and formulation, sterile filling, and visual inspection—supporting a 24/7 operation that keeps patients at the center.
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The Technician 3, Maintenance is responsible for the installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime.
we are hiring for multiple positions - day shift
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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 Quality Control group at FUJIFILM Biotechnologies in Research Triangle Park, NC 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.
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The Scientist 1, QC Compendial Testing participates in the Technology Transfer (TT) of material methods into the FUJIFILM Biotechnologies, Holly Springs Quality Control Laboratory, with limited supervision. This includes the onboarding of new and generic raw materials as part of new customers/programs. This role provides assessments, identifies QC compendial testing requirements and executes action items as part of change controls for the onboarding of these materials based on vendor documentation. This position also identifies materials together with customers in a cross functional team as well as provides technical knowledge to assess testing approach, verification and validation needs both...
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The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). The role executes MSAT strategy, builds and develops a team of scientists and engineers, and optimizes large scale cell culture operations across seed/production bioreactors and purification trains. With a focus on innovation and reliability, this leader drives technical stewardship through tech transfer execution, process performance qualification (PPQ) execution, commercialization, as well as continuous improvement initiatives. This leader partners closely with the rest of the MSAT leadership team, Manufacturing, QA, Automation, and...
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The Maintenance Technician I, under the supervision of the Facilities Maintenance
Supervisor, or designated supervisor will be responsible for performing various aspects of utilities,
facilities and process equipment maintenance and support for the Texas Biological Facility (TBF),
the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing
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The Finance Business Partner is a critical role that delivers strategic financial insight and decision support to functional and site leaders, enabling performance management across the contract manufacturing portfolio. This role leads planning, budgeting, and forecasting cycles; develops management reporting and variance analysis; and translates operational drivers into actionable financial plans while ensuring adherence to IFRS, company policies, and industry-specific financial practices. The position requires exceptional organizational skills, strong FP&A and commercial finance acumen, and outstanding communication to influence cross-functional stakeholders. The successful candidate...
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Help deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 4 to assist with the execution and documentation of manufacturing processing activities in a cGMP environment. The role supports project-phase readiness and steady-state operations in a 24/7 facility—helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required.
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The Engineer 2, Black Utilities provides engineering support to field personnel in the performance of maintenance and operational tasks associated with
Black Utilities, including HVAC systems, Chilled Water Systems, Steam Boilers, Cooling Towers, HVAC and Glycol Chiller and Compressed Air Systems. This
role works directly with other Utility Engineers to ensure applicable safety and regulatory standards are maintained, identify process improvements, and
assist with troubleshooting equipment issues to maintain overall plant reliability.
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Help deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 3 to assist with the execution and documentation of manufacturing processing activities in a cGMP environment. The role supports project-phase readiness and steady-state operations in a 24/7 facility—helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required.
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Help deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 1 and 2 to assist with the execution and documentation of manufacturing processing activities in a cGMP environment. The role supports project-phase readiness and steady-state operations in a 24/7 facility—helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required.
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The Senior Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Biotechnologies, Holly Springs provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FUJIFILM Biotechnologies, Holly Springs Quality. The Senior Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.
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The Associate Director (AD), Program Quality Management is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The Associate Director, Program Quality Management works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and...