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Overview Performs any basic to complex Analytical assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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We are seeking a highly motivated Vice President of Operations who will be responsible for the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
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The MGH PET Center is a cGMP registered Positron Emission Tomography (PET) radiopharmaceutical manufacturer which produces sterile injectable radioactive drug for diagnostic imaging procedures at MGH. We produce several different PET drugs for a variety of clinical and clinical research indications, including clinical diagnostic imaging of cancer with F-18 Fludeoxyglucose.
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Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200+ employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area.
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AA or BA/BS in a technical field (biotechnology, chemical engineering, bioengineering, microbiology, biochemistry) or equivalent experience, and experience working in a cGMP industrial setting. Our ideal candidate brings previous experience in a cGMP bioprocess or biotechnology setting, and enjoys working with precision in a fast-paced, changing environment, while bringing attention to detail, collaboration, passion, and dedication to their work.
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Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics.
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Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Has a basic understanding of cGMP and quality systems. Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
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Is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Work with Analytical Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
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You'll collaborate closely with our Process Liquids Solutions Technical Sales Executives (TSEs) to identify and cultivate opportunities for custom cGMP process liquids manufacturing services, aimed at simplifying bioprocess workflows both upstream and downstream.
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PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
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A minimum of 10 years in similar cGMP environments with broad knowledge of Quality Control procedures, bioanalytical, chemistry, microbiology assays for sterility, endotoxin, TOC, and stability programs required for biologic therapies.
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The Senior QA Associate, Compliance/QA Lead will be responsible for identifying, closing, and implementing corrective actions regarding gaps in current good manufacturing practices (cGMP) related activities to comply with FDA regulations, support Serialization and aggregation process implementation for Granules Consumer Health.
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GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines.
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Performs routine functions and analysis (dependent upon experience) as required by the specific laboratory requirement in compliance with B. Braun and cGMP specifications. B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry.
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Assist in the development and help maintain compliance with various quality related programs including but not limited to CGMP, environmental monitoring, sanitation, allergen, HACCP, Preventive Controls, product recall, traceability, and internal audits.
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