Reference #: 395664 Site Name: Upper Merion Posted Date: May 7 2024

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.

Medicine Development and Supply (MDS) 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. Within MDS, Biopharm Drug Substance Development (BDSD) is responsible for the development, scale-up, and technology transfer of cell culture and purification processes to manufacturing facilities all over the world.  Our aim is to integrate innovative expression and process platforms, automation, data digitalization, and advanced analytics/modeling into the process development workflow.  An opportunity has arisen for an 'Investigator, Advanced Data Analytics' to work directly with project teams to deliver on advanced modeling approaches to accelerate development, increase fundamental understanding, improve risk assessments, and deliver more robust processes, products, and regulatory filings.

This includes the application of mechanistic, data driven, and hybrid modelling in process design, control strategy identification, and advanced process monitoring & control for large molecule drug substance process development.  The role will also work with our advanced data analytics team to incorporate process analytical technology (PAT) such as Raman and Capacitance sensing for real-time process monitoring approaches.

As an Investigator, you will be a member of a highly skilled team of scientists and engineers responsible for the development and optimization of cell culture and purification processes.  You will be responsible for developing and maintaining advanced process, PAT, and chemometric models that are utilized to monitor and control key aspects of bioprocesses.  You will engage with other groups within GSK to progress the deployment of such advanced models in the development, clinical, and commercial space.  Although predominantly lab-based, the role also involves important aspects of verbal and written communication and requires good organizational skills as well as a broader scientific knowledge.  Both individual and team working are required and therefore the role will suit a scientist with good interpersonal skills, ability to solve complex problems, eagerness to work across boundaries, self-motivation, and an open mindset. Key responsibilities include: As a matrix drug substance project team member, use mechanistic, data driven, and hybrid modelling to efficiently deliver priority team objectives including but not limited to process design, quantitative risk assessment, identification of critical process parameters, design space definition, and implementation of advanced model-based process monitoring and controls.  In addition, develop and maintain PAT (such as Raman, Capacitance, FTIR) chemometric models Use engineering, biological, chemical, or materials science knowledge to postulate mechanisms for bioprocess behavior and develop or modify existing mathematical models to describes those mechanisms Perform or provide guidance on model-based lab experimentatio and analysis (e.g., chromatography, PAT, purification, upstream bioprocess) required to develop (e.g., parameter fitting) and verify advanced models to accelerate process development Translate mathematical models to computer models using software platforms (e.g., gPROMS, SIMCA, Unscrambler, JMP, etc.) or by writing custom programs (Using MATLAB, Python, R, etc.) Contribute to the adoption of the modeling and PAT strategy for new products and processes and the validation packages to meet regulatory requirements Support CMC-wide adoption of advanced analytics for supporting the portfolio via GSK-wide grand challenges intended to embed modeling as a central pillar of process development Develop and maintain key system modeling platforms.  Leverage external expertise and funding through pre-competitive alliances. Serve as a leader in the modeling space by supporting upskilling and real-time support to expand the use of advanced analytics and process modeling across MDS Stay current with new modeling techniques through publications, conferences, and academic and precompetitive collaborations Comply with data integrity requirements for documentation of models, data, results, and conclusions in appropriate repositories, along with the requirements of quality, safety, and policies and procedures and ensure that GSK intellectual property is protected Foster a collaborative working relationship across the MDS organization, R&D pilot plants, and Commercial supply chain Present data and status reports to CMC matrix teams and senior management.

Why you?Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: A PhD in Chemometrics, Chemical Engineering, or a related subject with emphasis on data analytics, process modeling, or mechanistic mathematical modeling Experience in translating mathematical models into computer programs using MATLAB, Python, R, gPROMS, or similar software tools. Experience with bioprocesses, process monitoring and control, data science, and data analytics Experience in statistical science and related software tools that enable sound experimental design and interpretation of models Experience in creating chemometric and mathematical models from wide variety of PAT/spectroscopy data and independently design and execute work plans to support model development.Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience with mainstream chemometric techniques (multivariate classification, calibration, pattern recognition, PCA/PLS) and familiarity with design of experiments concepts and methods Experience in the use of advanced chemometric methods for process modeling (MSPC, MCR) and 'data wrangling' for signal processing and feature extraction Familiarity with other data driven machine learning methods (SVM, ANN, Bayesian modeling) or the application of hybrid empirical/mechanistic modeling. Good interpersonal, organizational, and communication skills.  Ability to work within a team and communicate effectively Experience with metabolic modeling and/or analysis of 'omics data Programming experience using languages/platforms such as MATLAB, SIMCA, CAMO Analytics, Python, R, gPROMS etc. Hands-on laboratory experience in biopharmaceutical process development or a related field#LI-GSK

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