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The Senior Manufacturing Associate will responsible for upstream unit operations (see expansion, bioreactor operations, cell culture harvest). The Senior Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP with minimal supervision and effectively communicate with the manufacturing supervisor and support groups.
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4+ years’ experience with cGMP biologics manufacturing and/or commercial cell therapy operations. Daily manufacturing of cell therapy products in a Grade A (Biological Safety Cabinet)/Grade B clean room environment, including open manipulations and use of cell processing equipment.
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About This RoleThe Manufacturing Sr Engineer I designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification.
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The MPS is a planned production engineering, manufacturing, and shipment schedule, in weekly capacity-constrained sections, that is derived from outputs of the Initial Project Planning Meetings (IPM’s) and consistent discussions and coordination with Technical Project Managers (TPM) and Production Project Managers (PPM.
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Use Lean Manufacturing, Six Sigma, and other techniques to analyze process data to determine capabilities as well as improvement. The Principal Tooling/Vision Engineer is a "hands-on" position that plans, directs, and coordinates manufacturing equipment and processes to produce high quality injection/blow molded plastic product.
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Manufacturing steps for upstream and downstream purification including but not limited to fermentation, buffer prep, homogenization, chromatography, ultrafiltration, sterile filtration and filling.
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The Director, External Manufacturing Procurement plays a pivotal role in shaping and executing GSK's procurement strategies for large molecule and vaccine drug substances from our external network.
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In addition, the Facilities & Maintenance Manager leads a team of Maintenance Supervisors, Mechanics & Electricians in the predictive & preventative maintenance activities related to PowerSecure’s manufacturing and office facilities, and equipment.
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Demonstrate knowledge and understanding of manufacturing process and Quality Systems. The Lilly RTP warehouse is a fully automated warehouse system with automated pallet conveyors, pallet exchangers, ASRS (Automated storage and retrieval system), and AGV (Autonomous Guided Vehicle) delivery of materials to the line.
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The Manufacturing Associate I/II - Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Manufacturing Support operations fundamentals, utilize knowledge and prior experiences to troubleshoot, and continuously enhance the daily manufacturing operation in the formulation of Media's/Buffers, leveraging your expertise with Stainless steel tanks / Vessels / Sums and the utilization of single-use bags with Mixers.
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Maintain clean tooling for extruders, injection molding equipment, assembly equipment, and other manufacturing equipment. Ensures accuracy and good documentation practices per company and Good Manufacturing Practice (GMP) standards.
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The ideal candidate should have project management skills in an R&D environment with the ability to facilitate optimization of processes to a mature manufacturing state, along with appropriate QA checks and measurements.
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Production Formulation: Operate and maintain highly automated process batching equipment with HMI/SCADA interfaces used for chemical weighing and reagent formulation in a cGMP compliant manner Provide feedback on design and operation of equipment to optimize manufacturing Check equipment during production runs for proper performance and assures the equipment is maintaining standard speeds and process times Troubleshoot simple to moderate equipment related issues.
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Job DescriptionThe Scientist will provide hands-on support to the lab’s process development, process monitoring, and manufacturing support work. Strong pipetting techniques requiredQualificationsSkills desired (nice to have):Knowledge of downstream purification and/or processing (experience with AKTAs / general chromatography, TFF/DFF, homogenization, etc.
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This Individual will provide leadership as the senior automation engineer for an aseptic manufacturing facility. The Specialist is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.
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manufacturing job Company: Biospace in Durham, Peoria, Arizona
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