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Extensive management experience in a cGMP testing laboratory environment, with knowledge of regulatory and compendial guidelines as related to cell-based assay requirements, aseptic processing, and biosafety of cell therapy products.
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The Senior Engineer I, Validation supports airflow visualization study (AVS), aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS) programs as a member of the Jump Manufacturing Sciences and Technology (MSAT) department.
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Good working knowledge of microbiological assays, pharmaceutical microbiology, aseptic technique and performing work in biosafety cabinets or laminar flow hoods. Execute the Environmental Monitoring activities and Aseptic Gowning Qualification activities for the production facility.
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The successful candidate will have experience in single-use and aseptic technologies as well chromatography and filtration theory and operations. Knowledgeable in chromatography and filtration theory, downstream development strategy, and process scale-up/transfer.
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Familiar with the US, EMA, and ICH regulations and guidance documents including aseptic guidance such as Annex 1. Train personnel in and qualify personnel for aseptic gowning. Experience with aseptic gowning and cleanroom operation activities.
$70,000 - $90,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Proficiency in aseptic technique and surgical site infection prevention practices. Proficiency in aseptic technique and surgical site infection prevention practices. Scrub experience in three or more surgical specialties (e.g. Ortho, General Surgery, Urology.
$42.19 - $77.81 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Aseptic Sanitization Operator works in a manufacturing facility and performs a variety of environmental service duties to maintain and sterilize the manufacturing suite and equipment. and other computer-based systems utilized in the manufacturing department (i.e., MES, HMIs, etc.
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This role reports to Bothell Site Quality Head. Duties/Responsibilities Extensive management experience in a cGMP testing laboratory environment, with knowledge of regulatory and compendial guidelines as related to cell-based assay requirements, aseptic processing, and biosafety of cell therapy products.
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Lundbeck Seattle Biopharmaceuticals (LuSBP) is seeking a highly motivated individual to join the Cell Culture Development (CCD) team as a summer intern, participating in upstream process development for biopharmaceutical products The successful candidate will learn aseptic cell culture techniques, bioreactor operation (250 mL to 200 L), cell culture media preparation, in-process analytical instrumentation, statistical experimental design, and data analysis with JMP Software.
$20 - $22 an hourInternExpandApply NowActive JobUpdated 4 days ago
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