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Consults and interacts with internal cross-functional teams and external clients and customers Operate equipment and apply analytical methodology utilized in the formulation development of parenteral dosage forms ( lyophilizers, compounding/filling equipment, mixing techniques, sterilization techniques, HPLC, KF, particulate matter, etc.
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Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling and lyophilization for liquid and lyophilized products.
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Formulation, filling, labeling, capping, packaging and visual inspection of vaccines •Assist in training new team members •Report all unusual, non-routine occurrences when performing tasks.
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Provide technical support for all start-up TS/MS activities (e.g., tech transfer, process validation, media & buffer recipe, formulation, filling & packaging) The scope of the role will initially focus on formulation, media & buffer preparation, Drug Product Filling & packaging and visual inspection operations, from facility startup through support of validation processes and commercial manufacturing.
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Provide troubleshooting for complex manufacturing equipment including formulation, filling, packaging/inspection and serialization lines. Experience with Drug Substance and Drug Product Equipment (Aseptic Filling Lines, Visual Inspection Machines, Label/Pack Lines, Ultrafiltration, Chromatography, Mixing Skids, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Clean in Place Skids, etc.
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This will include formulation and commercial process development for biologics (monoclonal antibodies, antibody drug conjugates, bispecifics and fusion proteins). The Biologics Drug Product Development group develops monoclonal antibodies, antibody drug conjugates (ADC), and other biologics using state of the art formulation and process technologies.
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Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
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And physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization). The candidate will support both the early-stage assessment of candidates coming out of the Discovery pipeline and the design and development of stable drug product formulation and manufacturing processes for biologics used in clinical trials.
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Hands-on experience operating Tablet, Capsule, Granulation manufacturing process equipment such as Tablet Press, Capsule Filling, Coating, wet and dry Granulator, FBD, encapsulation technology etc.
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As part of Amgen’s Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated. Author and/or own high-quality process technology transfer and other technical documents.
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The Automation Engineer II is an engineer responsible for enhancing programs across a broad spectrum of functions at the West Chester Site. In this role, you will lead and advise on projects spanning various departments within the site, including Formulation, Aseptic Filling, Automated Inspection, Device Assembly, Packaging, Building Automated System, AMHS, and a site-level Historian system.
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Experience with some of the following Automation systems (PLC, HMI, SCADA): Rockwell, Inductive (Ignition), Aveva (Wonderware), Siemens, Emerson (GE), or B&R. Experience with Data Historian and Visualization systems such as Aveva PI (OSI PI.
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Acts as single Point of Contact (POC) to drug product teams to provide expertise/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling.
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As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing servicesto pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.
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Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Responsible for Biodecontamination and appearance of all formulation and lyophilization production areas.
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filling formulation jobs
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