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Passionate about Fermentation process development and the role it plays in translating scientific discovery into commercial reality. The Bioprocess Development Fermentation Scientist II will join our Upstream Bioprocess Development team and will be responsible for the design, execution, and development of fermentation processes.
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GRAIL is seeking a Process Engineer II to join the Global Development & Operations department in Menlo Park, CA to transfer a high throughput DNA processing assay for a Laboratory Developed Test. In this position, the candidate will work closely with Assay Development, Reagent Development, Operations, Equipment, and Software teams as we develop operational and maintenance procedures and processes for a groundbreaking, high-throughput laboratory.
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Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
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The successful candidate will have strong technical, scientific, management and leadership skills, experience in process development through commercialization of biologics, process technology transfer, project management and the ability to influence across functions.
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Hands-on experience with a basic understanding of engineering principles, RF/microwave concepts, vacuum science/products, materials like metals and ceramics and process engineering, manufacturing science, etc.
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We have manufacturing locations in the United States, Canada, Europe, and Asia. With a heritage of technological excellence, our team serves customers in the communications, defense, medical, industrial, and scientific markets.
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Gilead Sciences currently has an excellent opportunity for a highly motivated scientist to join our Process Chemistry group in the Pharmaceutical Development & Manufacturing (PDM) organization.
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This role requires expertise in design controls, process development, product/technology transfer, and process validation. Experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
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In this position, you will work closely with the Process Development, Quality Control, Analytical Operations, Quality Assurance, Translational Medicine, Biometrics, and Regulatory team members and will contribute to flow cytometry-based assay development for product understanding of CARGO Therapeutics' pipeline candidates, method transfer and/or qualification, SOP/technical report authoring and review, method life cycle management, data analysis, and execution of routine analytical testing.
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Establishing and executing scientific experimentation plans for ECO Synthesis™ with scientists in the process development team. Providing routine troubleshooting and maintenance of process development instruments including reactors, HPLCs, purification skids and UF/DF manifolds.
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Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
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BA/BS in a scientific field relevant to the drug development process. ·Good understanding of FDA and EMA drug development and approval process. ·Comprehensive understanding of the overall drug development process.
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The candidate's main focus is development of device fabrication process for next generation DNA sequencing consumable cells. Pacific Biosciences is looking for an experienced individual to join the SMRT Cell Process Development team working on R&D for next generation devices.
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process development scientific jobs in Belmont, CA
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