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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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Oversee the development and optimization of manufacturing processes to ensure product quality, consistency, and scalability, by partnering with CMC FT members from BiopharmSci. Minimum of 10 years of experience in CMC development and manufacturing within the biotechnology or pharmaceutical industry, with a focus on cell therapy or regenerative medicine.
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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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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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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.
$77,000 - $132,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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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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Serve as the Quality SME on the Chemistry, Manufacturing, and Controls (CMC) Governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for technical transfers, new product introduction, clinical trial and commercial products to assure a compliant strategy is developed, executed and maintained.
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Lead the organization’s ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
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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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Provide support to local and offshore manufacturing groups to transfer products, maintain product quality and high yield. Develop test plans and test solutions to validate new product designs, support qualification and release to manufacturing.
$115,600 - $214,800 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
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Strong experience managing external manufacturing operations at CMO's/CRO's/CDMO's in relation to bioassays such as ADCC, CDC, ELISA, SPR, and Cell-based binding assays. Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
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Job Overview: The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical phases into commercialization.
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quality manufacturing jobs in South Boston, MA
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