GlaxoSmithKline
Associate Scientist, Upstream Process Development
GlaxoSmithKline, King of Prussia, Pennsylvania, United States,
Site Name:
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 Drug Substance Development role could be an exciting opportunity to explore.Biopharm Drug Substance 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. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.Within BDSD, the upstream development group is responsible for the development, scale-up, and technology transfer of cell culture processes to manufacturing facilities all over the world. Our aim is to integrate innovative expression and process platforms, automation, and advanced data analytics into the upstream process development workflow.As an Associate Scientist in Upstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of cell culture processes. Your primary focus will be on the scale-up and demonstration of mammalian cell culture unit operations supporting demonstration batches of 50 or 200 L scale. You will also be involved in all aspects of the development of cell culture 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. You will have access to the latest technology in small-scale as well as large-scale bioreactors and analytical instruments. You will perform experiments in state-of-the-art labs to determine the best conditions for growing cells and increasing product concentrations while meeting all quality specifications. You will also analyze data, form conclusions, and plan future studies in a collaborative environment. The successful candidate will require strong verbal and written communication skills, efficient organization, and a broader scientific knowledge. You will be working in a matrix team and therefore the role will suit a scientist with good interpersonal skills, the ability to solve problems, strong 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:Perform large scale studies (50 or 200 L scale) to demonstrate cell culture processes for therapeutic protein production, including monoclonal antibodies, and antibody-drug conjugates.Maintain a state-of-the-art 200L bioreactor laboratory and ensure adherence to departmental safety practices.Perform small-scale studies to develop or characterize cell culture processes.Document experiments accurately and in a timely manner.Support transfer of processes to cGMP manufacturing facilities.Author technical reports and relevant sections of regulatory filings.Interact with key partners (process development scientists, analytical scientists, manufacturing colleagues, and statisticians).Contribute to on-going technology development efforts within the department.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor’s or Master’s degree in Biology/Biochemistry/Chemical Engineering or related discipline with at least 2 years industrial experience.Experience with general laboratory procedures.Excellent oral and written communication skills.Preferred Qualifications:If you have the following characteristics, it would be a plus:Basic understanding of cellular metabolism, protein synthesis, and monoclonal antibody manufacturing operations.Experience in cell culture process development, technology transfer, or manufacturing operations.Experience in operation of large-scale single use bioreactors (50L and larger).Ability to analyze experimental results using statistical software or modeling tools.Experience with writing technical reports.Why GSK?Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.Continuously looking for opportunities to learn, build skills and share learning.Sustaining energy and well-being.Building strong relationships and collaboration, honest and open conversations.Budgeting and cost-consciousness.
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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 Drug Substance Development role could be an exciting opportunity to explore.Biopharm Drug Substance 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. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.Within BDSD, the upstream development group is responsible for the development, scale-up, and technology transfer of cell culture processes to manufacturing facilities all over the world. Our aim is to integrate innovative expression and process platforms, automation, and advanced data analytics into the upstream process development workflow.As an Associate Scientist in Upstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of cell culture processes. Your primary focus will be on the scale-up and demonstration of mammalian cell culture unit operations supporting demonstration batches of 50 or 200 L scale. You will also be involved in all aspects of the development of cell culture 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. You will have access to the latest technology in small-scale as well as large-scale bioreactors and analytical instruments. You will perform experiments in state-of-the-art labs to determine the best conditions for growing cells and increasing product concentrations while meeting all quality specifications. You will also analyze data, form conclusions, and plan future studies in a collaborative environment. The successful candidate will require strong verbal and written communication skills, efficient organization, and a broader scientific knowledge. You will be working in a matrix team and therefore the role will suit a scientist with good interpersonal skills, the ability to solve problems, strong 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:Perform large scale studies (50 or 200 L scale) to demonstrate cell culture processes for therapeutic protein production, including monoclonal antibodies, and antibody-drug conjugates.Maintain a state-of-the-art 200L bioreactor laboratory and ensure adherence to departmental safety practices.Perform small-scale studies to develop or characterize cell culture processes.Document experiments accurately and in a timely manner.Support transfer of processes to cGMP manufacturing facilities.Author technical reports and relevant sections of regulatory filings.Interact with key partners (process development scientists, analytical scientists, manufacturing colleagues, and statisticians).Contribute to on-going technology development efforts within the department.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor’s or Master’s degree in Biology/Biochemistry/Chemical Engineering or related discipline with at least 2 years industrial experience.Experience with general laboratory procedures.Excellent oral and written communication skills.Preferred Qualifications:If you have the following characteristics, it would be a plus:Basic understanding of cellular metabolism, protein synthesis, and monoclonal antibody manufacturing operations.Experience in cell culture process development, technology transfer, or manufacturing operations.Experience in operation of large-scale single use bioreactors (50L and larger).Ability to analyze experimental results using statistical software or modeling tools.Experience with writing technical reports.Why GSK?Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.Continuously looking for opportunities to learn, build skills and share learning.Sustaining energy and well-being.Building strong relationships and collaboration, honest and open conversations.Budgeting and cost-consciousness.
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