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Do you thrive in a fast-paced, highly regulated environment where precision, teamwork, and continuous improvement make a real difference for patients? Join our Drug Product team as a Manufacturing Associate III to lead hands-on operations across formulation, sterile filling, and visual inspection—while helping stand up and optimize a state-of-the-art DP facility.
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Join a high-growth biomanufacturing site and help ensure safe, compliant, and reliable production. As a Manufacturing Specialist I, you’ll be a hands-on problem solver who supports day-to-day operations, documentation, and continuous improvement—keeping batches on plan and the plant audit-ready.
You’ll be the go-to partner for manufacturing operations: coordinating batch readiness, improving templates and documents, resolving issues on the floor, and driving compliance activities that keep our products moving to patients.
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Help build and optimize a best-in-class LabWare LIMS v8 environment that powers Quality Control in a GMP setting. As Sr. Specialist 1, QC LIMS, you’ll configure, validate, and sustain a critical system that enables compliant, efficient testing—directly impacting product quality and patient safety.
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The Director, Quality Systems and Compliance provides strategic leadership for the site's Pharmaceutical Quality System (PQS), Audits and Inspections, Documentation Management, GxP Learning, and Quality Compliance programs. The role ensures sustainable inspection readiness, maintains compliance with global regulatory requirements, and drives continuous improvement across quality systems. The Director serves as a key site leader during customer audits and regulatory inspections and partners across functions to strengthen quality culture, data integrity, and operational excellence. The Director, Quality Systems and Compliance fosters a strong Quality Culture across teams and contributes to cohesive...
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The Program Quality Manager (PQM) serves as the primary liaison between customers and the FUJIFILM Biotechnologies, Holly Springs project team from the point of contract signature through program closure. This role works with customers and FUJIFILM Biotechnologies, Holly Springs project teams to align QC objectives and initiatives in contracted commitments with FUJIFILM Biotechnologies, Holly Springs Analytical Method Capabilities and the FUJIFILM Biotechnologies, Holly Springs company vision/mission (strategy and compliance). The Program Quality Manager ensures the timely completion of QC deliverables for customer programs. The Program Quality Manager handles an average load of 2-4 customer...
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The Field Service Technician – Level 4 will be considered a specialist for a single product line that the TSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to all technicians. Will be considered the SME on the service team and lead other technicians with support and repair as required. This position will require travel throughout the United States.
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The Field Service Technician – Level 4 will be considered a specialist for a single product line that the TSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to all technicians. Will be considered the SME on the service team and lead other technicians with support and repair as required. This position will require travel throughout the United States.
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The Field Service Technician – Level 4 will be considered a specialist for a single product line that the TSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to all technicians. Will be considered the SME on the service team and lead other technicians with support and repair as required. This position will require travel throughout the United States.
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The Field Service Technician – Level 4 will be considered a specialist for a single product line that the TSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to all technicians. Will be considered the SME on the service team and lead other technicians with support and repair as required. This position will require travel throughout the United States.
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The Field Service Technician – Level 4 will be considered a specialist for a single product line that the TSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to all technicians. Will be considered the SME on the service team and lead other technicians with support and repair as required. This position will require travel throughout the United States.
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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 Senior People & Culture Coordinator drives and coordinates the onboarding process for all new and transferring employees. This highly visible role liaises with cross-functional departments within and outside of the NC Region. The Senior PNC Coordinator manages multiple administrative priorities, competing deadlines as well as recurring and non-routine PNC processes.
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The Regional Sales Associate is responsible for providing regional support to assigned Regional Sales Manager. This support includes Assisting Territory Managers in closing opportunities, ensuring shipment is complete and customer inquiries. This individual will be a highly motivated, self-starter. Understands the needs of the Regional team and become an advocate for growth in the region. May provide training and knowledge transfer support, as well as coverage when Territories are open and/or Territory Managers are on vacation.
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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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FCDI is recruiting for a Senior Process Engineer to support continued growth and ongoing customer projects within the Process Development (PD) team located in Madison, WI. As a Contract Development and Manufacturing Organization (CDMO), FCDI’s PD team supports multiple customer programs by onboarding, developing, and transferring robust manufacturing processes for a diverse portfolio of iPSC-derived cell therapy products.
We are seeking an experienced, self-motivated, and detail-oriented process development engineer to serve as a technical...
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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 Human Resources Business Partner (HRBP) serves as a strategic advisor and trusted partner to business leaders, aligning people strategies with organizational goals. The HRBP works closely with leaders and employees to drive performance, support organizational effectiveness, and ensure a positive employee experience.
This role balances strategic partnership with hands-on execution, providing expert guidance across the full employee lifecycle while ensuring compliance with employment laws, company policies, and...
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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...