Scientific Leader, Drug Substance and Product Analysis
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Mar 5 2021 Are you looking for a challenging position that allows you to leverage your technical expertise working with novel analytical technologies to accelerate the delivery of biopharmaceuticals? If so, the role of Scientific Leader in the Drug Substance and Drug Product Analysis department could be an exciting 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 a Scientific Leader in the Drug Substance and Drug Product Analysis department, you will be a member of a highly skilled team of scientists responsible for the development, qualification, and implementation of various analytical methods and state-of-the art analytical technologies. You will lead efforts to develop methods 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. In this dynamic role, you may interact with other labs, internal and external to GSK, to support the training and transfer of analytical methods. As a Scientific Leader, you will perform and oversee the development, qualification, and transfer of analytical methods that employ such techniques as HPLC, cIEF, CGE, UV, CAD and MS. This role requires excellent verbal and written communication skills, impeccable organization, and broad scientific knowledge. Because the role will require both collaborative and independent work, the ideal candidate will also possess good interpersonal skills, an open mindset, and the capacity for self-motivation. The scientific leader will oversee and contribute to the development and qualification of various analytical methods focused on testing for product quality and/or process specific analytes. The role will involve accountability for the implementation of these methods as well as the direction of associated analytical control strategies across the biopharm process. As such, the scientific leader will engage with project teams and other stakeholders as well as interact with other labs, internal and external to GSK, to support the training and transfer of analytical methods. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/MS with at least ten years of experience or Ph.D with at least five years of experience. 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. Experience with the biopharmaceutical product lifecycle. Preferred Qualifications: If you have the following characteristics, it would be a plus: Hands-on experience and knowledge in method development of separations assays supporting biopharmaceuticals. Understanding of up and downstream process development. Working knowledge and experience in protein analytical & biochemical techniques such as HPLC, UPLC, capillary electrophoresis, spectroscopy in addition to LC-MS and other bioanalytical technologies 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK 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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