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Work in collaboration with the Analytical Development team to ensure timely transition of lab developed methods to GLP ready state. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes.
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Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies and potential commercialization.
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CORE JOB RESPONSIBILITIES: Accountable for microbiological testing on finished product, raw material, personnel, and environmental testing, and conduct routine interpretation of results (per documented procedures) on environmental monitoring sampling program (production materials, raw materials, environmental samples such as air, productive surfaces and personnel testing, water) and specialized samples as required for troubleshooting or as part of an improvement project.
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You will ensure the data and laboratory processes are in accordance with GLP/GCP and good documentation practice, and be responsible for the preparation and delivery of bioanalytical reports.
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Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
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CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking.
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Lithium-Ion Battery Development Engineers (Design, Product Creation and Testing) We’re seeking dynamic Lithium-Ion Battery Development Engineers to join our team and contribute as key individual contributors for a cutting-edge R&D project.
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As the Lead Battery Engineer, you are responsible for all aspects of the product design, development, qualification, and hardware production. Support the development of the Automated Test Equipment for acceptance and qualification testing.
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Completes complex work for research and development, CGMP and GLP studies and documents and reports data in a timely manner according to regulatory guidelines. Plans the conduct of a study; monitors study procedures to ensure data accuracy and report quality; conducts complex analysis and experimentation on substances, for purposes such as product and process development and application, quantitative and qualitative analysis and improvement of analytical methodologies.
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Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. Leadership experience in late-stage product development, scale-up, tech transfer, and process optimization of solid oral dosage and parenteral formulations is a plus.
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An ideal candidate would have a direct experience with microfabrication, stem cell culture, and/or cardiomyocyte testing. Hands on stem cell-based cell culture and fabrication of microphysiological systems – creating, maintaining, and testing cardiac tissue chip systems.
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Prefer product development experience, ideally covering all phases initial concept to manufacturing ramp up, as well as circuit design experience with a focus on mixed signal and embedded system hardware design.
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As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.
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Understanding of automation components PLC/HMI/SCADA including system design, development, programming, testing, simulation, commissioning. Support testing in simulation environment Siemens PLC/HMI/SCADA.
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Work with testing and product evaluation labs to establish correlations between in-vitro and in-vivo studies on ingredients and formulations. The qualified candidate will also work closely with the Personal Care product development team to evaluate new raw materials and establish a mechanistic understanding of these ingredients in skin care applications.
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glp testing product development jobs Title: senior laboratory technician
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