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You’ll identify emerging practices for biologics cell line development and manufacturing to shape scientific strategies and continued innovation. We are seeking aSenior Scientist, Biologics Cell Line Development to join our team in Boston, MA and help push the boundaries of biotherapeutic cell line development.
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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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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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Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
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Success is achieved through collaboration with internal and external partners in regulatory, analytical development, quality assurance and process development and operations and requires prior experience working in highly matrixed environments and with contract organizations.
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2) Serve as a resource, apply a general knowledge and understanding of the pharmaceutical product development process, particularly as pertinent to biologics and vaccines, to the design and conduct of projects where the specifics of the project are difficult to determine in advance.
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We are seeking a Scientist to join our Downstream Process Development Department - Process Sciences in Gaithersburg, MD. Qualified individuals will play a role in downstream process development; scale up, new technologies, and technical support of cGMP manufacturing for protein particle vaccines.
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Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Transfers and Introduces technology of cell therapy-based and therapeutic protein processes into manufacturing collaborating extensively with Scorpion’s Process Development group to develop cGMP-compliant, clinical-scale production processes.
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The Biologics group is responsible for various functions criticalfor drug development such as: antibody discovery, molecular biology, cell line engineering,protein engineering, biophysical analytics, and functional cell assays.
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A dynamic program manager with deep knowledge of the drug discovery and development process, including demonstrated experience with leading programs through preclinical development and regulatory submission, with a strong preference for early clinical development experience with biologics development and product candidates in immunology.
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Familiar level knowledge of the biologics drug development process is recommended. Familiar knowledge of GLP and GMP requirements as they pertain to protein and gene therapy process development and Quality Control (QC) testing is a plus.
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The Senior Director ensures phase-appropriate assay development requirements as programs progress through the stages of biologics drug development with a line of site towards development of assays which will be robust, reproducible and capable of being qualified and validated for GMP use, for commercial products.
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Demonstrated experience leading process development initiatives in support of cell therapies, or protein biologics manufacturing, early- and late-stage. Work collaboratively with process development leadership to develop and/or optimize cell therapy platforms (T cells and Stem cell therapies), to support Novartis Cell Therapy's multi-product portfolio of clinical development programs.
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They will also be a member of the Pivotal/Commercial Biologics Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies for all aspects of late-stage process development (Cell Culture, Purification, Drug Product, Analytical Sciences, MSAT, and Materials Sciences.
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Lead a group of scientists focused on upstream process development and oversee their professional development. The global Cell Culture Development (CCD) organization within Sanofi operates with the mission to develop robust, scalable and high productivity cell culture processes for Sanofi’s very diverse early and late-stage biologics pipeline.
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