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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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We are seeking an Associate Scientist to join our Downstream Process Development group in Gaithersburg, MD. Qualified individuals will be responsible for hands-on execution of downstream chromatography and filtration processes in support of process development, scale-up, process characterization activities, and technical support of cGMP manufacturing for proteins, nanoparticles, and virus-like particle (VLP) based vaccines.
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Serve as bioprocess SME that provides technical oversight in support of IND filling and to ensure that clinical manufacturing is successfully executed per schedule. Independently author technical reports of studies, protocols, SOP and risk assessments to enable technology transfer, manufacturing and IND activities.
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Provide advice in matters related to safety and pharmacovigilance which includes developing pharmacovigilance practices such as set-up and configuration of the safety database, signal detection, trend analysis, analysis of aggregate safety and adverse event data to identify safety concerns in Division-supported clinical trials and provide expertise in preparing reports related to the manufacturing of investigational products such as development safety update reports (DSUR.
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TTI is a world-class leader in design, manufacturing and marketing of power tools and accessories, outdoor product equipment, and floor care products. Our brands include Milwaukee®, AEG®, Ryobi®, Hart ®, Oreck®, Hoover®, Dirt Devil® and Vax.
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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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This position is responsible for directing all aspects of CMC (Chemistry, Manufacturing and Controls) for pharmaceutical drugs and agents as well as the analytical work associated with that CMC across all of the small molecule projects within Pharma Cinq and, potentially, gene therapy projects.
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The work will entail: The candidate will join a multi-disciplinary team of scientists working to advance the current state-of-the-art in nanocalorimetry-based measurements and expand the technique's applicability to monitoring of semiconductor manufacturing processes.
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10 years of experience in facilities management and engineering, with at least 5 years in a leadership role within a biopharmaceutical, CDMO, or gene therapy manufacturing environment. Familiarity with automation, process control, and HVAC systems tailored to biologics manufacturing.
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Interacts with Regulatory Affairs, and Manufacturing to ensure that regulatory submissions meet domestic and international standards and regulatory requirements. Collaborates with manufacturing, clinical and regulatory groups to ensure site quality.
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Manufacturing/Production experience (Preferred) Perform a variety of tasks involved in the manufacturing and assembly of products. We have openings for receptionist, data entry, customer service, collections, call center, administrative assistant, accounts payable clerk, accounts receivable clerk, file clerk, warehouse, assembly, production, forklift, machine operators, maintenance mechanics and office managers.
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Today, Xerox scientists and engineers are continuing our legacy of innovation with disruptive technologies in digital transformation, augmented reality, robotic process automation, additive manufacturing, Industrial Internet of Things, and cleantech.
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In this role, you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the Rockville Manufacturing Center (RMC) facility. Accountabilities:As the Associate Director of Quality Engineering, you will provide leadership, direction and mentoring to ensure that the QE organization is successful in meeting the quality and manufacturing objectives in support of site goals.
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Working knowledge of quality tools such as SPC (Statistical Process Control], FMEA, Root Cause Analysis, Lean manufacturing, Kaizen, Poka-Yoke, and other Six Sigma tools. In Quality Assurance activities preferably supporting a life sciences manufacturing technology, or cGMP Medical Device/Pharmaceutical environment.
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For Eyes is part of EssilorLuxottica, a global leader in the design, manufacturing, and distribution of ophthalmic lenses, frames, and sunglasses. BASIC QUALIFICATIONS Doctor of Optometry Commitment to quality patient care Knowledge of current Optometric theory & technology Strong communicator & listener Problem solving ability Solid Organization skills Employee pay is determined by multiple factors, including geography, experience, qualifications, skills and local minimum wage requirements.
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manufacturing job Company: Cbre in Gaithersburg, MD
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