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Solid working knowledge of various manufacturing platforms (Microbial fermentation process, IB recovery and refolding, CHO cell culture and purification, Pegylation, PEGylated protein purification etc.
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Support Cell Culture/Purification operations to produce a bulk drug substance product. Under the general direction of the Manufacturing Lead and overall direction of the Supervisor, the Manufacturing Associate executes all processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations.
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Ensure strong relationships with key stakeholder functions including Analytical Development, Cell Culture Development, Formulation Development, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic input.
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Cell Culture, Fermentation. At least 5 years of working experience in a cGMP regulated environment, with exhibited knowledge or proficiency in capital project engineering. The Project Engineer will be responsible for supporting projects to implement new equipment or modify existing equipment for bioprocess manufacturing facilities.
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Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques. Strong knowledge of regulatory requirements for biologics, including cGMP, ICH guidelines, and relevant pharmacopeial standards.
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Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish.
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Just is seeking a highly motivated cell culture manufacturing manager that desires a significant opportunity to improve worldwide access to biotherapeutics. Significant experience in cell culture operations required for the manufacture of biotherapeutics.
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Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. Production of blood component lots through cell culture, harvest, and cryopreservation.
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Duties include operation, maintenance, cleaning (CIP) and sterilization (SIP) of large scale cell culture bioreactors and associated operations such as media preparation, infection and harvest.
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Individuals with a scientific background, mammalian cell culture and cGMP experience needed. Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing.
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Master's degree in Biochemistry, Biotechnology, Microbiology, or related field; advanced degree (e.g., Master's required or PhD preferred). Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory Affairs, and R&D, to support product development, process improvements, and regulatory submissions.
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This will be the largest end-to-end cell culture CDMO provider in North America. Experience in Validation, cGMP Manufacturing Operations and/or Quality Oversight, in an FDA Regulated facility.
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Performs routine analytical testing including complex methods such as ELISA, bioassays, and Cell Culture for in process, product release, and stability samples on a daily basis. This position is responsible for performing activities to support analytical testing programs to ensure compliance with cGMP standards including in-process, product release and stability testing.
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Extensive experience in biologics manufacturing processes, including cell culture, purification, aseptic processing, and fill-finish, within a CDMO or biopharmaceutical company. Champion a culture of safety, quality, and compliance, ensuring adherence to cGMP regulations, environmental health and safety standards, and company policies.
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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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