Biopharmaceutical Stability Lead
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Aug 12 2021 Are you interested in contributing your detailed analytical knowledge of biopharmaceuticals while designing and managing the stability programs for biopharmaceutical projects in various phases of development ranging from Pre-Candidate Selection to Commercialization? If so, this Biopharmaceutical Stability Lead could be an ideal opportunity to explore. As a Biopharmaceutical Stability Lead, you will be proficient in authoring relevant CMC sections of regulatory submissions and have a strong understanding of statistical analysis as it pertains to stability data trending and product shelf-life applications. Key Responsibilities: Lead the design of biopharmaceutical stability strategies and implementation of stability work processes in-line with regulatory and business requirements Oversee external contract organizations with respect to stability testing and reporting Author and review stability protocols and reports Prepare analytical related content for relevant CMC sections of regulatory submissions Participate in agency meetings and inspections as the stability subject matter expert Participate and/or lead cross functional task forces when required to resolve specific technical issues Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/MS with more than 5 years or a Ph.D. with 1 year of experience in biotechnology or pharmaceutical industry Biopharmaceutical development experience with a focus on formulation development, analytical method development, and release and stability testing Experience managing project matrix teams and cross-functional task forces Theoretical understanding of the analytical techniques currently used to release and characterize proteins and/or oligosaccharides Preferred Qualifications: If you have the following characteristics, it would be a plus: GMP experience Deep understanding of ICH guidelines and compendial requirements Hands-on experience in various protein separation, biological assays, and other characterization techniques such as CGE, cIEF, HPLC/UPLC, mass spectrometry, and functional assays Highly motivated and instinctive team player with excellent communication skills, both written and verbal 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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