Biopharmaceutical Analytical Workstream Leader
Site Name: USA - Pennsylvania - Upper Providence, USA - Pennsylvania - King of Prussia Posted Date: Jun 10 2021 Are you interested in contributing your detailed analytical knowledge of biopharmaceuticals while managing cross-functional teams that are responsible for GSK's analytical strategies for projects in various phases of development ranging from Pre-Candidate Selection to Commercialization? If so, this Biopharmaceutical Analytical Workstream Leader could be an ideal opportunity to explore. As a Biopharmaceutical Analytical Workstream Leader, you will be proficient in authoring relevant CMC sections of regulatory submissions and have a basic understanding of Quality by Design (QbD) principles as applied to biopharmaceuticals. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Lead analytical sub-teams and provide oversight of analytical life cycle management Provide analytical regulatory strategy for biopharm projects. Prepare analytical related content for all regulatory submissions and participate in agency meetings Manage clinical and commercial specifications Lead analytical comparability and reference standard approaches Ensure methods are fit for their intended purpose Participate in technology transfers, qualifications, and validations as required Facilitate troubleshooting initiatives and GEMBAs across testing laboratories 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 1year of experience in biotechnology or pharmaceutical industry. Experience with managing project matrix teams and cross-functional task forces. Experience in the analytical techniques currently used to analyze proteins and/or oligosaccharides. Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience with biopharmaceutical development in a biotech environment. In-depth knowledge and/ or hands-on experience in various protein separation and other characterization techniques such as CGE, cIEF, HPLC/UPLC, mass spectrometry, and functional assays. Good knowledge of protein and oligosaccharide separation methods, and sound understanding of protein structure and function are essential to this position. Knowledge in QbD approaches to analytical lifecycle management including platform methods, specifications, CQAs, testing strategy, and reference standard. The candidate is expected to be highly motivated with excellent communication skills, both written and verbal. She or he should be an instinctive team player with excellent people skills. 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. 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