We are seeking 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.

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.

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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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 experimentation 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.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• PhD in Chemometrics, Chemical Engineering, or a related subject with emphasis on data analytics, process modeling, or mechanistic mathematical modeling
• Experience with bioprocesses, process monitoring and control, data science, and data analytics

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Knowledge of statistical science and related software tools that enable sound experimental design and interpretation of models
• Ability to translate mathematical models into computer programs using MATLAB, Python, R, gPROMS, or similar software tools
• 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
• 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
• Demonstrated ability to create chemometric and mathematical models from wide variety of PAT/spectroscopy data
• Demonstrated ability to independently design and execute work plans to support model development
• Good interpersonal, organizational, and communication skills. Ability to work within a team and communicate effectively

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