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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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Demonstrate basic knowledge of the GXP cellular therapy product manufacturing, and program development and evaluation, as well as needs assessment and marketing of the programWorking knowledge of flow cytometry, molecular biology, and genetic engineering is a plus.
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The successful candidate will join the Process Development Team and work on process development, optimization, process scale-up, and technology transfer of Client products and processes into Manufacturing.
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Rapid prototyping involving additive manufacturing, carbon & glass fiber/epoxy composites. Work with the lead engineer, design, analysis, testing, and manufacturing teams to achieve project goals.
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Technical Implementation Specialists will become experts in manufacturing processes such as CNC machining, sheet metal fabrication, and 3D printing. Familiarity with “job shop” manufacturing, preferred.
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Requirements Requires an advanced degree in Pharmaceutical Sciences, Chemistry, Materials Science, or related field with 5+ years of experience in process development and manufacturing of peptide and oligonucleotide APIs including PMOs. Experience with solid phase peptide/oligo synthesis preferred.
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Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)Manage upstream and downstream scientistQualifications:M.S or Ph. D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience & prior management experienceExperience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc.
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Sourcing Strategy Development - Develop and execute sourcing strategies for raw materials used in cell and gene therapy manufacturing. Market Analysis - Stay informed about market trends, supplier capabilities, and emerging technologies related to raw materials for cell and gene therapy manufacturing.
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The Principal Scientist, Aseptic Control, is recognized as having expertise in the principals and application of sterile and low bioburden processing technologies and providing technical support for manufacturing of cell and gene therapy (C>), small molecule, and combination medical device programs within cCMP manufacturing.
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You will be working alongside lab SME, Data Engineering, and the Emerging Technologies team to help digitize our process development, analytical development, and manufacturing workflows and enable cross-functional access to data.
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With support from the CCBB Site Coordinator and BWH Center for Clinical Investigation, manage the coordination of umbilical cord blood donations for public banking and research, ensuring compliance with SOPs and regulatory standards for Tissue Manufacturing.
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Assists in keeping the Pharmacy neat and clean by caring for equipment and cleaning after compounding prescriptions, manufacturing bulk medications, unit dosing, etc. An organizational related support or service (administrative or clerical) role or a role that focuses on support of daily business activities (e.g., technical, clinical, non-clinical) operating in a “hands on” environment.
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All-around training in all areas of tool making and conventional soft machining, CNC Machining, hard machining, heat treatment, precision grinding, precision ram EDM, precision wire EDM, mold making, die making, electrode manufacturing, proto-typing, machine assembly and debug, planning, quality and metrology.
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In-depth knowledge of cell and gene therapy products, technologies, and manufacturing processes. Familiarity with regulatory requirements, quality standards, and best practices in the pharmaceutical industry, including Good Manufacturing Practices (GMP) and ISO standards.
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Interface with construction and manufacturing teams to ensure faithful and profitable execution of VBC projects. Utilizing our technology-enabled design and engineering model, precision-driven manufacturing capabilities, and project-proven modular construction expertise, the company’s focus is on providing high quality, sustainably produced buildings in less time across varied market sectors including housing and hospitality.
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manufacturing job Title: business analyst in Boston, Danbury, Connecticut
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