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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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The primary responsibilities are to develop and execute global (with an emphasis on US and EU) CMC regulatory strategies towards regulatory adoption of innovative approaches to biologics product and process design, and manufacturing; to lead and manage CMC matters for internal and external products and.
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Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes.
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Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization.
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The primary focus of this job is to lead and guide the Quality Control functions supporting Just-Evotec's Biologics Manufacturing state of the art J.POD Facility, located in Redmond, WA. This highly qualified candidate will partner with Quality Assurance, Manufacturing Operations, Technical Operations, Materials Management, F&E, Process Development and EH&S functions to ensure GMP and regulatory compliance.
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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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IT Systems Analyst GMP systems page is loaded IT Systems Analyst GMP systems Apply locations Redmond Seattle Toulouse time type Full time posted on Posted 3 Days Ago job requisition id JOB ID-10511 Just-Evotec Biologics is seeking a highly motivated and creative IT Systems Analyst to join a fast-paced, collaborative, and multidisciplinary team to provide support with manufacturing and process development systems.
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Just-Evotec Biologics is seeking a highly motivated and creative IT Systems Analyst to join a fast-paced, collaborative, and multidisciplinary team to provide support with manufacturing and process development systems.
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SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs.
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This position requires strong collaboration skills, including working with Process Development, Quality Control, Engineering, Site Technical Operations, other sites, and others to ensure timelines are met for activities related to Quality Control and the Site. Continue to build and enhance various Quality Assurance programs by guiding individuals through the maturation process.
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Oversee routine analytical testing and coordinate study support across Quality Control (QC) and Process Development (PD) groups. Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of novel therapeutic antibody programs with a focus on methods to determine the potency of drug product for early through late-stage clinical development programs.
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GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.
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