Investigator, Modeling & Simulation 208046
As Investigator, Modeling & Simulation you will be responsible for: Implement System Modeling (Simulation) directly on key projects to increase fundamental understanding and greatly reduce labor, materials and time required to identify commercial Drug Substance and Drug Product processes. Upskill project team members to expand the use of simulation and work with internal and external experts to development /maintain core simulation software platforms. Champion integration of new ways of working into existing QbD work flows (e.g. Process Design, Control Strategy Identification, Risk Assessment), regulatory filing strategies and life cycle planning.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: As part of a matrix Drug Substance or Drug Product project team, use System Modeling to efficiency deliver priority team objectives including but not limited to Process Design, quantitative Risk Assessment, Identification of Critical Process Parameters / Design Space and implementation of advanced process controls. Use engineering, chemical or materials science knowledge to postulate mechanisms for physiochemical processes and develop or modify existing mathematical models to describes those mechanisms. Perform or direct experimentation and analysis (e.g. chromatography, PAT, physical properties testing) required to develop (e.g. parameter fitting) and verify system models. Translate mathematical models to computer models using software platforms (e.g. gPROMS, Aspen and Dynochem) or by writing custom programs (Using Matlab, Python, etc.) Development and maintain key system modeling platforms. Leverage external expertise and funding through pre-competitive alliances (e.g. System base Pharmaceutics) Provide or coordinate training and real-time support to expand the use of system modeling (simulation) across PDS, BPDS and PSC. Work closely with the QbD and DoE communities, Regulatory and other experts to integrate system modeling (Simulation) into QbD process development. Work closely with Statistical Science to develop the best in-silico experimental design and to engage them to assess model uncertainty and model predictive confidence limits. Stay current with new modeling techniques through publications, conferences and academic and precompetitive collaborations Advocate and comply with GMP requirements for recording experiments and associated data and writing modeling sports including scientific review and data checking. Comply with requirements of Good Manufacturing Practice, Safety, Quality for the Patient and GSK policies and procedures (sites and department). Provide input to budget decisions, recommend capital purchases of software supporting modeling and monitoring activities. As a member of a project team, provide critical support outside area of expertise if required to make sure projects meet development timelines.
Basic Qualifications: PhD in Chemical Engineering or equivalent experience with an emphasis on development and implementation of mechanistic mathematical models. At least 5 Years Experience in relatable field. Ability to translate mathematical models into computer programs using Matlab, Python, gPROMS or similar software tools. An understanding of statistical science and related software tools that enable sound experimental design and interpretation of models. Good lab skills including the ability to independently design and execute experimental plans and perform any related analytical testing. Experience with engineering software such as Dynochem, Aspen or gPROMS. Good interpersonal, organizational and communications skills. Understands and complies with GSK and government Environmental, Safety and Health requirements. Understands and complies with GMP requirements including; data integrity and model validation / maintenance.
Our values and expectationsare 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, rigor 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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