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Advanced degree (BS, MS or PhD) in Chemical/Biochemical Engineering, Biochemistry, Immunology, or related degree with experience (8+ for BS, 5+ for MS, 2+ for PhD) in process development and manufacturing sciences in cell therapy, biotechnology, or pharmaceutical industry.
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Support technology transfer of mRNA/LNP manufacturing process to internal or external manufacturing facilities for clinical and commercial manufacturing, in collaboration with Manufacturing and Quality teams.
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Provide expertise for the scale up, optimization and tech transfer, and validation, of upstream cell culture and viral vector unit operations to internal and external partners in support of clinical manufacturing of HilleVax's vaccine products.
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Proven track record of developing novel processes, designing experiments to define QA/QC parameters for setting a process envelope, and scaling processes to support manufacturing capacities.
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The Biomedical Engineer will focus on optimizing, characterizing, and qualifying growth chamber designs, materials, fabrication, packaging, and sterilization for current Good Manufacturing Practices (cGMP)-compliant clinical use.
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We're expanding our External Manufacturing/ Manufacturing Science and Technology (MSAT) team for a Process Engineer to support manufacturing for our clinical trials in metastatic melanoma and non-small cell lung cancer.
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Possess continuous improvement experience with emphasis in the laboratory information management and deployment of LEAN/Six Sigma, analytical methods and manufacturing process development for polymeric materials.
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Characterize process & product failures on our manufacturing line, root cause investigations, corrective actions, and mistake-proofing at suppliers and contract manufacturers for component/module/product new builds and refurbishments.
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Key Responsibilities of a Process Development Engineer: Design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.
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We offer a portfolio of integrated additive manufacturing solutions for engineers, designers and manufacturers comprised of hardware, software, materials and services. Convincing communication skills and decision making ability for both the development of long term customer relationships and achievement of goals within the company.
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At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
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Research Associate/Senior Research Associate, Process Development Company Overview GC Therapeutics is the first genome-wide cell landscape exploration company using an integrated synthetic biology and AI-driven platform for cell programming.
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Ability to select and perform analytical techniques for physical and chemical characterization of solids and aqueous solutions. Sublime's breakthrough replaces the industry's legacy fossil fuel-fired kilns with an electrochemical system that operates at ambient temperature, eliminating the use of fossil fuel and the need for limestone, resulting in low-carbon, low-embodied energy cement.
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Support Elektrofi pilot plant unit operations to provide robust manufacturing procedures used to process monoclonal antibody drug substance and drug product for IND enabling studies.
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Providing expertise for the scale up, tech transfer, GMP run readiness of downstream unit operations in support of clinical/commercial manufacturing of HilleVax’s vaccine products. Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development and Manufacturing.
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