Site Name: USA - Pennsylvania - King of Prussia Posted Date: Oct 24 2024 Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Investigator, Biopharm Downstream Process Development role could be an exciting opportunity to explore. Biopharm Drug Substance 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. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience. 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 Investigator 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, 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, nanofiltration and continuous centrifugation. Although predominantly lab-based, the role also involves verbal and written communication and requires good organization as well as a broader scientific knowledge. Both individual and teamwork 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: Designing, executing and interpreting protein purification experiments Applying Quality by Design principles to process design Utilizing statistical analysis and advanced data analytics for process understanding and improvement. Working with matrix teams in Biopharm Process Development Sciences to integrate results into process designs and overall project plans Scale-up and technology transfer of manufacturing processes. Evaluating and integrating innovative purification technologies Writing and reviewing technical documents, authoring of CMC sections for regulatory filings Mentoring junior scientists Presenting data and status reports to senior management Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry; or related Biological Science, OR a BS/MS and 8+ years of industry experience. Experience in protein purification and protein chemistry. Experience in process development Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to apply expertise to identify and evaluate new technologies for process development. Expert in protein purification and process development Demonstrated record of scientific achievement and a broad and integrated knowledge of the field. Experience in scale-up and technical transfer for clinical and commercial manufacturing Knowledge of continuous processing. A developing understanding of regulatory standards (viral safety, process validation, GxP, etc.) Knowledge of Quality by Design and control strategy development Demonstrated ability to work as part of a project team. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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