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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 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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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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Director/Sr. Director - Process DevelopmentGreater Boston Area Competitive Compensation + excellent bonus/benefitsDuties and Responsibilities:Lead all process development activities (cell culture/banking/development, fermentation, protein purification, tech transfers)Oversee internal(in-house) and external vendors (domestic & international CDMOs)Work cross-functionally with CMC & Manufacturing leaders such as Analytical, Drug Product, QA/QC, Manufacturing, Supply Chain, etc.
$210,000 - $240,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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 across a product life cycle to assure a compliant strategy is developed, executed and maintained.
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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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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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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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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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Experience in design, construction and set-up/validation of new cell therapy manufacturing facilities is essential. The role will have ownership of a fully established clinical cell therapy manufacturing facility and have responsibility to mentor a team of associates comprising manufacturing operations, external manufacturing, Manufacturing Sciences and Analytical Technologies, supply chain and manufacturing systems and validation.
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In-depth knowledge of rapid-prototyping and volume manufacturing processes including 3D printing, CNC machining, and injection molding. Effectively utilize CAD designs to bring early-stage concepts through to cost-effective manufacturing and sourcing.
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Field Service Engineer One of gpac's top clients, a leading manufacturer of precision CNC manufacturing cutting tools, is seeking a traveling Field Service Engineer with remote office. Field Service Engineer One of gpac's top clients, a leading manufacturer of precision CNC manufacturing cutting tools, is seeking a traveling Field Service Engineer with remote office.
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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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Strong cross-functional experience and extensive domain knowledge of Oracle Cloud SCM modules (Inventory Management, Cost Management, Procurement Management, Demand Planning, Supply Planning, Product Information Management, Warehouse Management) and good understanding of supporting ERP Manufacturing & Quality Management Cloud modules.
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manufacturing job Company: Abm Industries in Boston, CA, Us
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