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This individual is a critical member of the Biomanufacturing team and will oversee all biologics cGMP clinical manufacturing activities including, technology transfer, upstream cell.
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Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities). Just - Evotec Biologics' Bioreactor Process Development group is seeking an enthusiastic and hardworking team member who is passionate about expanding worldwide access to biotherapeutics through the advancement of continuous bioprocessing technology and mammalian cell culture processes.
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Experience with upstream and/or downstream bioprocessing equipment, especially perfusion technology. Serving as a team member for platform early-stage (FIH) or technology development projects; may also serve as a team member for complex early-stage (FIH) or late-stage Process Characterization (PC) projects.
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Quality Control Scientist IV , demonstrates full understanding of scientific and technical aspects of biological Drug Product/ Drug Substance (DP/DS), as well as technology transfer, assay qualifications and validations activities.
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Demonstrated experience with the execution of Technology Transfer and scale up programs for commercial manufacturing processes of parenterals. The scientist will also ensure the transfer of robust manufacturing processes to CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO. The scientist will also ensure robust process performance at CMO during commercial manufacture by use of continuous process verification, Operational Excellence (OPEX) principles, etc.
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Participate in technology transfer activities, providing expertise in cell culture processes and contributing to process improvement initiatives. Cgmp, Sop, Laboratory, Cell culture, CDMO, aseptic technique, Seed thin, Ultra Filtration, biotechnology, BioPharma, Cleanroom, Aseptic, Manufacturing process, Gmp.
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Downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activities.
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Create and execute project plans for process and assay development and support the transfer of processes to cGMP manufacturing and quality control. As the Associate Director of Process Development, the individual will be responsible for creating protocols and methods for the production of various cell and gene therapy products, procuring the necessary equipment and components for cGMP production, making adjustments to the process and reagents to meet cGMP requirements, facilitating technology transfers, and developing assays for product characterization.
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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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Write and revise cGMP documents related to technology transfer and production and materials management (SOP’s, MBR’s, DR’s, etc.,) Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
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Support cGMP manufacturing and technology transfer to our internal manufacturing facilities and external contract manufacturers. Advance enabling technologies to accelerate pharmaceutical development and to improve sustainability and process efficiency, including advances in biocatalysis, high-throughput technology, flow chemistry, and AI/machine learning.
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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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This individual will be supporting technology transfer to establish a commercial-scale process and to assist the manufacturing team to support cGMP clinical manufacturing for clinical trials.
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Industry giant seeks an experienced Process Development Scientist to develop protein purification processes to be scaled up and transferred into cGMP manufacturing including evaluation of transferred processes, transfer of processes to manufacturing, harvest clarification, normal flow filtration, purification, tangential flow filtration, and product final formulation.
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Lead and manage NPI quality activities including prototype testing, process validation, and technology transfer ensure successful product launches. The Senior Quality Assurance Specialist (Engineer) ensures compliant manufacturing procedures, equipment, and facilities in our new manufacturing facility in adherence with cGMP requirements, Quality Standards, and other regulatory requirements.
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