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Perform routine laboratory support tasks (e.g. waste disposal, dishes, housekeeping, sample receiving and handling, etc.).
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Provide first and second line technical support to internal staff. Work with applications / systems to undertake analysis, diagnosis, and resolution of staff problems which may range from straightforward to more complicated technical issues.
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Provide first and second line technical support to internal staff. Work with applications / systems to undertake analysis, diagnosis, and resolution of staff problems which may range from straightforward to more complicated technical issues.
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Under supervision comply with cGMP, current SOPs, safety and environmental guidelines. Perform warehousing duties and staging of raw materials for manufacturing operations. Prepare shipments of finished product and miscellaneous items for outside processing. Perform inventory, cycle count, and receiving transactions using Noven’s integrated systems (MRP / DSI) to ensure inventory and location accuracy. Assist with the delivery of small packages and mail delivery as needed. Work as an effective team member, to ensure that the department’s quality and performance expectations are met. Forklift operation is required.
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Under supervision comply with cGMP, current SOPs, safety and environmental guidelines. Perform warehousing duties and staging of raw materials for manufacturing operations. Prepare shipments of finished product and miscellaneous items for outside processing. Perform inventory, cycle count, and receiving transactions using Noven’s integrated systems (MRP / DSI) to ensure inventory and location accuracy. Assist with the delivery of small packages and mail delivery as needed. Work as an effective team member, to ensure that the department’s quality and performance expectations are met. Forklift operation is required.
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Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
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Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
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Performs Quality tasks such as sampling and inspections designed to ensure incoming materials/components are dispositional in a timely manner and are in compliance with internal SOPs, safety initiatives, company policies, FDA and DEA regulations. Documents all work performed, ensuring accuracy and thoroughness. Informs Management of any quality issues, failures or deviations from established standards/procedures.
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The primary role of the Manager QC Raw Materials is to manage the QC Raw Material testing program in support GMP manufacturing. This role will work closely with the other QC personnel, Quality Assurance, Manufacturing, Process Development, Analytical Technologies and Supply Chain to ensure incoming raw materials are sampled and tested in a timely manner to support manufacturing operations. Develop and implement methodologies for the qualification and testing of Raw Materials, and components utilized in finished products and developmental products; troubleshoot analytical instrumentation within the laboratory. Managing the activities of the QC department and leading the development and implementation of best practices, processes.
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Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.
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Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures.
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Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.
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Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.
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Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.
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Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.
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Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures.
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The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.
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The Director, Clinical Pharmacology provides strategic scientific and technical leadership across all aspects of Clinical Pharmacology and model-informed drug development, including study strategy, pharmacokinetic (PK) and PK/PD analysis, modeling and simulation, and regulatory submissions to support early- and late-stage clinical development.
This role serves as a key cross-functional leader with regulatory affairs, clinical operations, clinical research project management, data management, biostatistics, and external partners to ensure clinical pharmacology strategies and deliverables are aligned with corporate objectives, regulatory expectations and internal standard operating...