Team Director, Process Analytics
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Aug 16 2021 Job Description: The Team Director, Process Analytics will lead a team of approximately 5 to 12 System Modelers, Chemometricians, Process Analytical Technology (PAT) scientists and Kineticists that work across modalities to deliver advanced modeling approaches and PAT technology that accelerate development, increase fundamental understanding, improve risk assessment and deliver more robust processes, products and regulatory filings. This includes the application of mechanistic modeling (e.g. Kinetics, Material Science Predictive Modeling and System Modeling), data driven modeling (e.g. MSPC, MVA, Optimization and Machine Learning) and PAT (established and new technologies) in process design, control strategy identification and advanced process monitoring & control for small and large molecule Drug Substance and Drug Product processes. This role has accountability for delivering high quality statistical and mechanistic simulation modelling solutions to project teams across modalities so that our products are robustly developed, sources of variation are diagnosed, and product performance is verified. In addition to delivering the insight to solve challenging development problems through simulation modelling, a key purpose of this role is to continue to build GSK's modelling capability and ensure that it is at the fore of regulatory expectations, through regular engagement with regulators and industry peers. The job holder will provide leadership to the team, including prioritization of project resourcing and the development of scientific capability in core areas. Additionally, the job holder is accountable for oversight of activities performed by external partners and leadership of external advocacy and collaboration activities. Key Responsibilities: Provide strong technical leadership to their direct reporting line that ensures that the modeling and PAT vision, strategy and objectives are clear, a plan is in place to achieve and that stakeholders/sponsors are supportive. Drive implementation of advanced modeling approaches and PAT technology on projects that improves performance by accelerating development using in-silico experimentation, increasing fundamental understanding and delivering more robust processes, products and regulatory filings. Build GSK capability in Digital Design. Develop and deliver a matrix of modelling solutions to; 1) enable sound product and process design using “predict-first” approaches, 2) support the development of design space through the application of modelling, 2) assess sources of product variation and recommend courses of action to reduce these and 3) verify/control the performance of our products to deliver improvements in product quality. Implement solutions rapidly and efficiently using internal and/or leveraging external expertise through pre-competitive, academic and government funded alliances. Critically understand forward regulatory expectations and trends through regular engagement with regulatory bodies (particularly the US FDA) and industry peers. Translate these expectations into GSK's approach to the application of modelling/PAT. Ensure that modelling solutions are used to deliver robust control strategies for NDA/MAA or other regulatory documents and ensure Quality by Design regulatory expectations for control verification are met or exceeded. Align with Automation and Data Science groups in R&D and Pharma Supply Chain to deliver modeling and PAT solutions more efficiently. Prioritize and manage modeling software budgets, working closely with IT and software suppliers to ensure modeling tools are in place to support the needs of project teams. Ensure that technical excellence is maintained within the group and that staff are developed to their fullest potentials by providing coaching, mentoring, and appropriate learning opportunities for all team members. Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected. Basic Qualifications: Chemical Engineering or related degree 5+ years of experience in small or large molecule drug substance or drug product pharmaceutical process development. Demonstrated experience using modelling, PAT and predictive tools in process design, control strategy identification and advanced process monitoring & control and track record of delivering innovative modelling solutions. Strong people leader to engage, motivate and develop a team of technical professionals. Highly effective interpersonal, organisational and communication skills for working in a multi-disciplinary high-paced scientific team environment. Preferred Qualifications: 10+ years of experience in small or large molecule drug substance or drug product pharmaceutical process development with demonstrated practical experience in modelling Advanced degree in Chemical Engineering, Data Science or related field preferred. Recognized as a technical expert internally and externally in their area of expertise. A strong understanding of mechanistic modeling (e.g. Kinetics, Material Science Predictive Modeling and System Modeling), Data driven modeling (e.g. MSPC, MVA, Optimization and Machine Learning) and PAT (Established and new technologies) outside of their primary area of deep technical expertise. Extensive knowledge of the pharmaceutical industry with particular focus on the development and manufacture of medicinal products. A wide range of experience with different pharmaceutical manufacturing modalities and platforms. A working knowledge of Quality by Design (QbD) principles and their application. 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