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Experience must include 6 months in each of the following: mechanical engineering; MES; 5S; Kaizen; Six Sigma; Quality Tools; Lean manufacturing; VSM; PFMEA; and Computer-Aided Design (CAD) software.
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Keywords: Manufacturing Associate, manufacturing, incubators, bioreactors, depth filtration skids, single-use mixers, centrifuges, washers, autoclaves, tanks, In-processing instruments, Cleaning equipment, steam sterilization, GMP, Biosafety Cabinet Operations, Bioreactor Operations, aseptic technique, chromatography, filtration, raw material weigh out, downstream, upstream, depth filtration, column packing, TFF.
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6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation. As Gene Therapy Manufacturing Lead, you will play a critical role in helping to establish REGENXBIO's first internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability.
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0-2+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
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The Operations Manager will lead all aspects of a multi-product (Cell Therapy, & Single Use Assemblies/Final Fill Solutions) operation at the Life Sciences Manufacturing Facility in Gaithersburg, MD. Will ensure customers' expectations are exceeded by leading the plant to its full potential, delivering high quality products at market leading levels.
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Lead early stage pipeline programs, including process development, scale-up, toxicology material production, technology transfer, clinical material manufacturing support, analytics, formulations and IND submissions, to support development of molecules leading to commercialization.
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DeltaV Control System Configuration: Utilize your expertise in Emerson DeltaV to configure and program control systems for process automation in pharmaceutical manufacturing environments. Join our team and contribute to the advancement of pharmaceutical manufacturing through your expertise in Emerson DeltaV controls and Syncade MES interfaces.
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The qualified individual will bring experience in relevant analytical technologies, such as ELISA, SRID, Luminex, or BLI. The position will perform in-process testing, as needed, to support the Process Development, Formulation Development, and Manufacturing teams, in addition to method development and qualification.
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Support design efforts with fluid dynamics, seismic/structural dynamics, electrical, neutronic, manufacturing, and other systems to understand impacts and ensure compatibility with each. Support hardware development and prototype manufacturing and testing efforts as a cognizant engineer.
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Design, Solidworks, Mechanical, Mechanical engineering, medical device, electromechanical devices, manufacturing process, Engineering, Gd&t, fluidics, mechatronics, robotics, Comsol, Matlab, Python.
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Serves on team projects (i.e. qualifications, investigation) in the role of testing support and initiation of investigationResponsible for completing laboratory housekeeping to ensure safety and complianceIdentifies areas for improvement or gaps in both safety and compliance (ZAPs/ZIPs)Effectively communicates issues/hurdles to supervisor and/or managerSupports GSK site initiatives and departmental goalsJob requires gowning into GMP manufacturing spaces to collect samples.
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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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Analyze laboratory experiments to support cell culture process development and GMP processes transfer activities to enable clinical manufacturing. Participate in technical transfers to CMOs and provide manufacturing science and technology support to ensure robust production in a GMP environment.
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ATCC, a pioneer in biomaterials manufacturing, is seeking a P roduct Manager with Cell Biology background to work a hybrid schedule. Health & Wellness: Comprehensive medical coverage and company paid Life Insurance, Disability Insurance & AD&D Work life balance with Paid Holidays and PTO Fitness and cell phone subsidies, and additional benefits such as Aflac, legal services, and pet insurance Employee Assistance Program offering around-the-clock counseling.
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The Associate Scientist, Quality Control (QC) reporting into the Senior Director, QC will execute QC operations in support of manufacturing and will have technical lab experience and have strong industry experience.
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manufacturing job Title: vp Company: Ashley Furniture in Germantown, MD
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