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Must possess proficient knowledge and understanding of regulatory guidelines and industry best practice for validation requirements within aseptic processing, clean rooms, and semi-solid manufacturing.
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Biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream. Experience in aseptic processing techniques and some understanding of regulatory requirements for a cGMP manufacturing facility.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Prior experience with cGMP operations or aseptic technique. Familiarity with general chemistry, microbiology, or clean room operations. Work is performed in a biologics manufacturing environment with classified areas requiring clean hygiene, specified gowning, and personal protective equipment (PPE.
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Develop and author necessary supporting cGMP documentation that supports all Cell Culture manufacturing processes. Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Job Summary: This long-term career opportunity is with a nation-wide pharmaceutical manufacturer located in Chicago, IL. In this role, you'll use aseptic techniques to prepare solutions and operate pharmaceutical manufacturing equipment in a cGMP environment.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Keywords: Microbiology, Bioburden, Microbiologist, QC, Endotoxin, Environmental Monitoring, cGMP, Microbial Tests, cGMP, Aseptic Technique, Pharmaceutical, Growth Promotion. 1+ years of experience working in a cGMP microbiology laboratory is preferred.
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We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services.
$10Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Responsible for Successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
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Perform testing for Artiva's cGMP EM program, including non-viable particulate monitoring, viable air, and surface monitoring using aseptic technique. At least 3-5 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Microbiological assays of samples under cGMP and GLP guidelines. to, aseptic technique, microbial challenge studies, bioburden determination, facilities, equipment, and utilities under cGMP guidelines.
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Includes preparation of all solutions, buffers and all activities associated with an aseptic production area, such as room and equipment cleaning and moving equipment as needed. Must have a strong working knowledge and complies with cGMP guidance as applicable.
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Extensive knowledge of industry guideline including cGMP and regulatory guidelines (i.e. FDA, EU, ICH, ISO). Our client is a new aseptic fill/finish contract manufacturer of sterile injectable products, located in Spokane, Washington.
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Knowledge of key technologies including aseptic technique, pre-fill syringe line, Isolator technology, and compounding of products. Participate in CGMP client audits to uphold and ensure the highest standards of quality.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility are required. Provide oversight of the manufacturing process, ensuring technicians follow cGMP practices and utilize proper aseptic techniques.
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Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP, and JP monographs for microbiology. Comprehensive knowledge of global GMP regulatory requirements for Aseptic Controls.
$150,000 - $217,500 a yearExpandApply NowActive JobUpdated 4 days ago
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