Investigator, Drug Substance and Product Analysis
Site Name: USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper Providence Posted Date: Oct 1 2021 Are you looking for a collaborative analytical chemist role that allows you to contribute to scientific strategy and accelerate Pharmaceutical Research and Development? If so, this role could be an ideal opportunity to explore. GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better, and live longer. Product Development and Supply 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. As an Investigator, you will design and perform experiments that develop, qualify, and implement various analytical methods and state-of-the art analytical technologies that focus on product quality and/or process-specific analytes and support various aspects of biopharmaceutical process development and manufacturing. You will be involved in all aspects of the biopharmaceutical development, including engagement with project teams and other stakeholders for various projects in different stages of development. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and support assays that support the development, release and stability testing of drug substance and drug product. Review of experiments, stability protocols, and other key documents Influence the direction of associated analytical control strategies across the biopharm process. Contribute and support departmental cross-training activities on analytical techniques used for analysis of biopharm molecules. Independently writes and edits sections for patents or regulatory submissions, authors scientific papers and internal reports. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS with 5+ years' experience / MS with 3+ years' experience /PhD 3+ years' experience in analytical separations methods such as HPLC, uHPLC, cIEF, or CGE. Experience with assay development/qualification/validation, pharmacopeia compliance, and analytical life cycle management. Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience with the biopharmaceutical product lifecycle including an understanding of up and downstream process development. Experience with analytical support of challenging biopharmaceutical formulations Working knowledge and experience in protein analytical & biochemical techniques such as HPLC, UPLC, capillary electrophoresis, LC-MS or 2D-HPLC. Analytical Quality by Design approaches. 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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). 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