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Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up. 15 plus years' experience in pharma/biotech industry with significant management experience in upstream/downstream process development and manufacturing of protein therapeutics.
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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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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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Its patent-pending and proprietary pluripotent stem cell differentiation technology platform TFomeTM was developed in Professor George Church’s lab, a pioneer in synthetic biology, and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency and speed.
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Process Engineer Position Summary:Catalent Pharma Solutions is Chelsea, MA is hiring a Process Engineer who is responsible for assisting senior engineering staff in the design and implementation of manufacturing processes, instrumentation and equipment for clinical and commercial manufacturing.
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At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
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Act as the key contact to SQF practitioner, OSHA and for all plant manufacturing practices & maintenance. Contact: John@SourceRecruitmentSolutions.com Our client, a premier Food Manufacturing Company with products sold nation wide is seeking an experienced Quality Assurance Manager.
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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. Preference for individuals with experience leading a function or department in Process Development, Analytical Development, or Manufacturing at a Director or Senior Director level.
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Hands-on knowledge of cGMP and CMC regulatory requirements for cell or gene therapy manufacturing. As we strive to halt degenerative diseases, we seek talented CMC leadership to lead tech transfer to our late-phase and commercial CDMO, manage DP production for our Phase III trials, prepare the CMC strategy for BLA submission, and build a manufacturing organization for commercialization.
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The Senior Director, Financial Planning & Analysis - CMC will play a critical role in leading the financial business partnering support for select Chemistry, Manufacturing, and Controls (CMC) functions, including Quality, Engineering, and Supply Chain, overseeing $1+ billion in operating and capital spend.
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The incumbent will provide Automation support to the daily operations, continuous improvement, and projects for the Pilot Plant, Bulk Manufacturing, Filling, Assembly, Packaging, Utilities, Facilities, and other DCS and PLC Automated Equipment and Control Systems on a GMP regulated environment.
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Familiarity with electronics assembly processes including fabrication (Screen Printing, Pick-and-Place, Reflow Oven), rework (hand soldering, hot gas rework), validation tools (Xray, inspection microscopy) and cable / harness manufacturing methods and equipment.
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Reporting to the Associate Director, Systems Engineering- Internal Warehouse, the Associate Software Engineer will support the design, development, implementation, and technical support of SAP EWM across a pharmaceutical manufacturing environment.
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Familiarity with chemistries used in electronics manufacturing including flux systems, solutions, and various epoxy and coating systems. Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions.
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You will manage a cross-functional, collaborative team to develop new manufacturing processes and equipment, ramp-up to full-scale production, and drive continuous improvement of the production line.
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manufacturing job Title: associate research Company: Puffy in Mattapan, MA
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