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The Senior Project Manager 1 is responsible for leading cross-functional project teams and driving end-to-end project execution — from initiation and planning through delivery and closure — within a regulated industry environment. This role ensures that all projects are delivered on time, within scope and budget, and in full compliance with applicable regulations, quality standards, and organizational policies. Serving as the primary point of contact for project stakeholders, this role facilitates transparent communication, manages risks and issues proactively, and aligns cross-functional resources to achieve project objectives. Additionally, this role requires...
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The QA Specialist, Operations (Days 2-2-3 0600-1800) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
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The Technician 1, Electrician is responsible for the operation, maintenance, and optimization of plant electrical systems. This includes but is not limited to medium voltage switch gears, transformers, and low voltage distribution panels. This role monitors and operates process control systems and equipment in assigned process and utility areas and troubleshooting and maintaining the electrical equipment to ensure these systems meet the stringent requirements of pharmaceutical manufacturing and storage environments. This role is part of a team required to support 24/7 operations.
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Make medicines better, faster, and more reliably. Join us as an MES Specialist I and own the end‑to‑end design, configuration, testing, and lifecycle support of electronic Master Batch Records (eMBRs) in Werum PAS‑X. You will translate manufacturing science into digital workflows that run our drug product operations—driving right‑first‑time execution, data integrity, and compliant performance.
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The Technician 2, 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.
this role is for Night shift (2-2-3)
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Join a high‑growth biologics manufacturing team that’s bringing lifesaving therapies from concept to clinic. As a Senior Manufacturing Associate, you’ll lead day‑to‑day operations on a 24/7 manufacturing floor and play a hands‑on role in getting our new facility fully operational. If you love cGMP precision, coaching teammates, and solving problems on the fly, this is your next move.
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Senior Employee Relations Partner is critical in supporting managers and leaders to maintain a fair, harmonious workplace that supports organizational goals.
Senior ER Partner will have current employment law knowledge and will manage and deliver a
caseload of employee relations cases. In addition to upskilling managers on the management of...
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Make an impact Help us run a world-class drug substance manufacturing operation that’s safe, compliant, and always ready. As a Manufacturing Specialist, Manufacturing Support, you’ll be the bridge between the manufacturing floor, quality, and engineering—keeping batches on plan, documents up to date, and the site audit-ready while driving continuous improvement.
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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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The Senior Automation Engineer 1, Project Delivery, leads the Automation activities associated with the site expansion with two additional Drug Substance Manufacturing (DSM) buildings. This includes overseeing the implementation of changes to the Automation systems, updating design documents, executing testing, and troubleshooting events. This role leads projects and handles complex changes while coordinating with other internal and external groups.
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The Senior Accounting Manager is a strategic, hands-on leader overseeing end-to-end accounting operations, internal controls, and regulatory financial compliance. Owns the integrity of accounting systems and critical integrations across the business, ensuring accurate, timely financial data flow. Leads the financial close process, drives financial audit performance, and designs, implements, and continuously improves robust internal control frameworks. Partners cross-functionally to optimize processes, strengthen compliance (GAAP/J-SOX), and enable scalable growth, while mentoring the accounting team and elevating reporting quality and operational efficiency.
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This is a night shift position supporting our 2/2/3 schedule from 6pm-6am. There is a 20% shift differential for night shift.
The Utility Operator 2 operates, maintains, and repairs black and clean utility...
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The Supervisor, Drug Product Filling supports start up and operational activities for the site. This role leads a shift team and is responsible for the manufacturing process and facility which will eventually operate 24/7 model.
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The Automation Engineer 3, PLC will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. Specific areas of concentration are PLC controlled equipment such as Water and Steam Generation Skids, Centrifuges, Autoclaves, and Parts Washers utilizing Siemens and Allen-Bradley PLCs and HMIs.
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The Maintenance Coordinator supports the day-to-day execution activities within the assigned function (e.g., Maintenance, Instrumentation & Controls, Utility Operations, etc.) by facilitating work order readiness, ensuring tool and material availability, managing technician workflow, and serving as a liaison between maintenance, production, quality, and other support teams to maintain optimal equipment performance with minimal downtime. This role provides input to maintenance protocols, participates in cross-functional initiatives that drive organizational efficiency, and ensures compliance with Current Good Manufacturing Practice (CGMP), safety, and company procedures. Additionally, this role is aligned to specific shifts or provides rotational coverage, as needed to support...
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The Technician 2, HVAC is responsible for the installation, maintenance, and repair of the heating, ventilation, air conditioning, and refrigeration systems/equipment. This role ensures these systems meet the stringent requirements of pharmaceutical manufacturing and storage environments. Additionally, this role is responsible for conducting regular inspections and preventative maintenance on HVAC/R systems to ensure they are operating within the required specifications.
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The Sr. Analyst 1, QC Raw Materials is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FDBN Quality Control Laboratory. Following Tech‐Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods
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The Warehouse Specialist 2 supports the activities and processes related to storage, handling, and distribution of materials and products. This role supports, all Supply Chain Warehouse operations, procedures, systems, processes, and GxP related matters in accordance with the GxP requirements. This role supports Warehouse operations in receiving, shipping, and/or logistics and works cross-departmentally to support operations. The Warehouse Specialist 2 uses and/or assists the team with SAP Enterprise Resource Planning software (ERP) system for inventory management, cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures...
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The Raw Material Sampler 2 position is responsible for sampling of materials and products. This role works with multiple functions to support operations (e.g., Warehouse, Supply Chain, Quality Control (QC)). The Raw Material Sampler 2 uses Systems and Applications Production (SAP) Enterprise Resource
Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).
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The Associate Manager, Strategic Sourcing & Procurement leads and elevates various sub-work streams within the Procurement function. This role will drive best practices among site-based procurement teams, drive adoption of standardized sourcing processes, and lead key strategic sourcing initiatives to deliver cost savings/avoidance, operational efficiencies, supplier performance improvements, risk reduction, and compliance in a regulated environment. The ideal candidate is a hands-on leader with strategic sourcing experience in life sciences or biopharma, comfortable managing a small team while partnering cross-functionally to influence outcomes and realize results.