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GlaxoSmithKline

Associate Scientist - Biopharm Downstream Process Development

GlaxoSmithKline, King of Prussia, Pennsylvania, United States,


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USA - Pennsylvania - King of PrussiaPosted Date:

Oct 4 2024Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Associate Scientist, Biopharm Downstream Process Development role could be an exciting opportunity to explore.Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development.Within Biopharm Drug Substance Process Development, the Downstream Process Development department is responsible for the development of purification processes for the manufacture of GSK’s Biopharm assets. The Department is also responsible for the scale-up and tech transfer of the processes to manufacturing facilities all over the world. Our aim is to integrate innovative process platforms, automation and advanced data analytics into the downstream process development workflow. In our mission, we follow the science and are committed to the design, development, and transfer of the most robust, well-understood, and well-characterized downstream manufacturing processes and platforms that will ensure quality and reliable supply of medicines for the patient.As an Associate Scientist in Downstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of purification processes. You will be involved in all aspects of the development of purification processes including initial process screening, optimization and characterization, scale-up and tech transfer to clinical manufacturing and/or commercial manufacturing partners for therapeutic proteins including monoclonal antibodies, and antibody-drug conjugates. Your primary focus will be on the bench-scale laboratory development of purification unit operations such as column chromatography (affinity, ion exchange, HIC, mixed mode, etc.), ultrafiltration, depth filtration and continuous centrifugation. Although predominantly lab-based, the role also involves verbal and written communication and requires good organization. Both individual and team working are required and therefore the role will suit a scientist with good interpersonal skills, self-motivation and an open mindset.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Bench-scale laboratory development of purification unit operations such as column chromatography (affinity, ion exchange, HIC, etc.), ultrafiltration, depth filtration and centrifugationInitial process screening; optimization and characterization; virus clearance validationScale-up and tech transfer to clinical manufacturing and/or commercial manufacturing partnersExecution and documentation of scientific experiments in a timely manner and with high qualityBasic Qualifications:We are looking for professionals with these required skills to achieve our goals:Master's degree (Chemical Engineering, Biochemistry, Chemistry or Biology) or Bachelor’s degree plus at least 2 years of industry laboratory experienceKnowledge of protein chemistry and purification techniquesKnowledge of routine laboratory techniques or plant equipment/operationsPreferred Qualifications:If you have the following characteristics, it would be a plus:Purification process development experienceBasic knowledge of GxP policies and procedures; basic knowledge of regulatory requirements of the pharmaceutical and/or biotechnology industryExcellent verbal and written communication skillsStrong organizational skillsDemonstrated ability to learn new techniques independently

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