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The Senior Coordinator, Manufacturing Technical Operations (MTO) supports compliance management for quality records, including Deviations, CAPAs, Change Controls, Risk Assessments, and Quality Control Analytical Investigations, across Biopharma Cell and Gene Therapy (CGT) in Boston, Cambridge, and Providence.
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Its patent-pending and proprietary pluripotent stem cell differentiation technology platform TFome™ was developed in Professor George Church’s lab, a pioneer insynthetic biology, and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency, and speed.
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The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Testing/Manufacturing sites.
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Provide technical support for control systems throughout the facility, including quality control instruments, clean utilities, process development equipment, GMP manufacturing systems, and the building automation system.
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ETQ part of Hexagon Manufacturing Intelligence division is seeking a Director Growth Marketing. ETQ, part of Hexagon, is the leading provider of quality, EHS and compliance management SaaS software, trusted by the world’s strongest brands.
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Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products.
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Create and implement robust, scalable, and high-quality automation solutions for a manufacturing environment. Parker Chomerics is a world leader in the development and manufacture of high-quality products that enable engineering breakthroughs for a cleaner and more sustainable world, including thermal interface materials, EMI shielding solutions, electrical grounding products, and conductive and non-conductive injection molded plastics.
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The Quality organization at Mural is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GvP), and Good Manufacturing Practice (GMP.
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In this role, the Supplier Quality Engineer will collaborate and team-up with cross functional teams including R&D, Procurement, Manufacturing Engineering, Factory Operations, Operations Quality, Supply Chain teams amongst others to manage suppliers involved in new product development and sustaining production.
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Demonstrates extensive ability to collaborate with Microsoft Dynamics 365 Technical Architects, clients, engineering teams including developers, testers and PMO to deliver a quality product and implementation.
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Interacts effectively and transparently with internal stakeholders in the areas of Analytical Development, Drug Substance Development, Program Management, Preclinical Development, Clinical Development/Operations, Quality, Regulatory Affairs, and external business partners.
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Collaborate with cross-functional teams, including the CDMO joint project team, Abata Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to ensure the efficient execution of clinical manufacturing operations and the transfer of new assets and process enhancements within agreed timelines to support business objectives.
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The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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Position Overview: Fusion Optix is seeking a highly skilled and detail-oriented Quality Technician to join our Assembly Group responsible for manufacturing specification grade LED lighting products.
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High level of expertise in stem cell biology, process engineering, and project management, ensuring the successful development and implementation of cell therapy manufacturing processes. In this key role, you'll lead the development and production of high-quality media and cell therapy intermediates, as well as drug products, to support our Cell and Gene Therapy projects.
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quality manufacturing jobs in Cambridge, MA
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