Expert Scientist, Separation Sciences and Sizing
Site Name: USA - Maryland - Rockville Posted Date: May 26 2021 Are you interested in the design and development of analytical methods to support product and process development? If so, this Scientist role could be an ideal opportunity to explore. As a Scientist in Analytical R&D, you will be responsible for performing analytical method development and routine sample testing on investigational vaccine programs as they progress from early development to clinical PhI/II and PhIII trials. In addition, with the analysis of clinical material, you will also support process development and be involved in analytical method transfer to GMP/QC sites. You ensure implementation of state-of-the-art technologies in line with QbD approach in the area of separation sciences (mainly liquid chromatographic and electrophoretic techniques). You are responsible for the quality of scientific data generated, you plan experimental activities according to business priorities and you can present and share your conclusions with external audience. This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of this position include some of the following: Analyzing and characterizing recombinant glycoproteins, mRNA vaccine candidates and also product/process impurities with : Liquid chromatography (RP, IEX, HILIC, Affinity, SEC, HIC) paired with UV/Fluo, CAD, ECD, RI, ELSD UV spectrophotometry for protein and/or oligonucleotides quantification electrophoretic techniques such as capillary electrophoresis (CGE, CZE, cIEF) and gel electrophoresis (SDS-PAGE, IEF-PAGE) compendial assays (pH, osmolality, description) Designing and executing specific development projects in collaboration with the related platform staff, following the Quality by Design framework. Driving innovation in Separation sciences team: investigate, propose and implement new approaches (chemometrics, 2D…) Interpreting scientific and technical data to reach sound scientific/technical conclusions based on a balance of data, analysis and experience Supporting junior scientists in the successful execution of their routine activities, providing guidance and act as a resource for colleagues with less experience. Collaborating with related platform staff to design, implement, and interpret the data from development workstreams. Functioning as a core team member on several projects in parallel. Solving complex problems through collaborations with others, taking a new perspective on existing solutions. Generating strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally, to strengthen development/implementation of new methods/technologies. Preparing and presenting scientific data within Technical R&D / Technical Development team and Analytical team meetings Be able to defend scientific data to external events. Authoring and reviewing technical protocols and reports in support of various project development stages. Using technical process knowledge to meet regulatory requirements appropriate for stage of development. Communicating effectively within TRD and with external stakeholders. Encouraging adaptation and proactively promoting the GxP / EHS / QA rules that are under application Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD degree (+5yrs) in an R&D (bio)pharmaceutical environment Experience in analytical method development and performance evaluation using UHPLC-UV-Fluo-CAD, CE and SDS-PAGE techniques for Ph1/2/3 release and characterization of candidate vaccines Expert in the use and the troubleshoot of Waters & Agilent LC systems Experience with Empower and Chemstation softwares Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong presentation and writing skills Good stakeholder management skills - aptitude to collaborate efficiently with other functions within Technical R&D department and internal partners (QA, RA, Stats) The successful candidate must have great interest in technical aspects of analytical separation by LC and/or electrophoresis Ability to evolve in an international organization Good understanding of product development stream for vaccines Advanced computer skills with MS office applications (Excel, Word, Outlook, Teams) Experience with : -Maurice iCIEF, Agilent Bioanalyzer, PA800 instruments -Chromeleon and/or 32-karat softwares Being familiar with mRNA characterization using separative technologies Good understanding of the analytical QbD approach Experience with in-house column coating Interest to participate to external events (symposiums, congresses) and present your work Previous experience in analytical method transfer to GMP facilities Broad overview of guidances (ICH) and regulations (USP,EP) in the field of physico-chemistry (including compendial assays) for releasing and characterizing candidate vaccines that will be used in Ph1/2/3 clinical trials is a plus 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. 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