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Responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
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Responsible for CMO management for early and mid-stage programs, including technology transfer, analytical support and CTM production at appropriate CMOs for early and mid-phase programs.
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As a Digital Biomarker Lead reporting to Head of Digital Health Technologies you will be play a pivotal role in developing and incorporating digital biomarkers within clinical programs and revolutionizing clinical research at Regeneron.
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Works with Scientists in technology transfer from bench scale to full scale manufacturing Our ClientOur client is an award-winning clinical development company. Experience with Scientists/Manufacturing Technology in technology transfer from bench scale to full scale manufacturingWell-developed communication skills, both verbal and writtenWhat Do You Think.
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This involves the startup of a new commercial manufacturing site, technology transfer, and process validation. Fundamental understanding and application of technology transfer and validation processes.
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We are seeking a Head of Process Engineering to join the Manufacturing, Science and Technology (MSAT) team and support ongoing process development, manufacturing of GMP grade material for company's Phase 1 and 2 clinical trials, technical transfer from preclinical to clinical Phase 2, IND authoring and agency interaction activities.
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The CES Ops portfolio is dynamic in nature; study types include, but are not limited to, less complex data transfer agreements, retrospective sample/data acquisition studies to more complex prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies.
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Own technology transfer and implementation of new production processes, with the objective to produce new clinical trial products within the facility. Opened in 2023, the facility serves as a central location where customers and UCSF researchers will have access to Thermo Fisher Scientific's broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support to our partners.
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Collaborates with Process Development, Manufacturing, Analytical Development, Quality and Clinical operations to ensure successful completion of technology transfer and transfer of process improvements to TScan's internal and external manufacturing facility.
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This role will drive the planning, execution and external partner interaction for the MSAT function during technology transfer from clinical through Commercial manufacturing. 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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The ideal candidate should have relevant experience in cell therapy process development, technology transfer to GMP manufacturing and GMP principles related to cell therapy, and enjoy fast-paced, collaborative and vibrant startup culture.
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Reporting to the Pharm Tech Snr Manager you will be responsible for various activities to support the tech transfer of New Product Introduction (NPI) to accommodate clinical manufacture of Biological products.
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Responsible for the timely execution of Technology Transfer plans to CMO in preparation for clinical trials and commercialization. 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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Provide expertise for the scale up, tech transfer, and validation, of upstream cell culture and viral vector unit operations to internal and external partners in support of clinical/commercial manufacturing of.
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In this position, you will perform cell culture process development, scale-up, and technology transfer activities in a well-supported and dynamic environment to help advance novel biotherapeutics into human clinical studies.
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