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Working knowledge of aseptic technique and preparation of sterile IV products and chemotherapy agents. Comprehensive knowledge of current pharmacological/biopharmaceutical principles, medical terminology, pathologies, disease states, and related information for a medical management plan.
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Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Follows strict garbing procedure to work in aseptic filling area. We're looking for a QA Analyst , working in Biotechnology/Medical Devices industry in Fort Worth, Texas, 76134, United States.
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Seeking a Bioanalytical Lead to join a specialty biopharmaceutical group Job Description: Perform laboratory experiments for client project. Minimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols.
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Produce blood component lots via cell culture, harvest, and cryopreservation with a focus on aseptic techniques. Advanced proficiency in cell culture techniques and familiarity with cell culture, cryopreservation, purification, and aseptic techniques.
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3+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing. To excel in this role, the candidate strongly desires a background in cell culture, aseptic gowning, qualification, and ISO class 5 cleanroom operations.
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Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications. Support onboarding and technical training of Manufacturing Operators on process equipment including Syring Fillers with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.
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Accountable for maintaining area of operation in compliance with cGMP requirements, cUSP requirements (as appropriate), environmental health and safety policies, and all governmental regulatory requirements for the biopharmaceutical and plasma derived blood products industry.
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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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The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of 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.
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The Associate Aseptic Manufacturing Technician is an entry-level position for our autologous cell therapy manufacturing program. Minimum 0-1 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
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1-5 years experience in viral vector/cell therapy (or biopharmaceutical) based GMP manufacturing operations including direct experience in cell culture, cell selection, recovery, purification, and/or aseptic fill/finish.
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Biopharmaceutical manufacturing, and aseptic environment experience. INCOG Biopharma Services is seeking a Senior Project Manager to manage projects in aseptic. biopharmaceutical manufacturing environment.
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For various levels you must have the following: Associate Process Controls & Validation Scientist r: 0-2 years of relevant experience Process Controls & Validation Scientist: 2 years of relevant experience Sr. Process Controls & Validation Scientist: 5 years of relevant experience Experience in aseptic processing, drug substance development, drug product development or biopharmaceutical/ combination production validation is preferred.
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Must have a thorough knowledge of cGMP and regulatory requirements for validation of equipment and computerized systems in the biopharmaceutical or pharmaceutical industry. Utilize isolator and VHP decontamination to enable Aseptic processing of Pharmaceutical products.
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