New

Process Analytics Team Director

GlaxoSmithKline
United States, Pennsylvania, Collegeville
1250 South Collegeville Road (Show on map)
Jan 15, 2025
Site Name: USA - Pennsylvania - Upper Providence, USA - Pennsylvania - King of Prussia Posted Date: Jan 14 2025 Process Analytics Team Director will lead a team of approximately 5 to 8 Process Modelers and Chemometricians, who will work to deliver advanced modelling and digital twins for large molecule biopharm drug substance projects (monoclonal antibodies, ADCs, bispecifics) for accelerating the development, increasing fundamental understanding, and delivering more robust processes, products and regulatory filings. This includes the development of Level 1 process simulation (mechanistic and hybrid models, and system models) of upstream bioreactor and downstream unit operations (e.g., chromatography), Level 2 digital shadow (e.g., multivariate statistical process monitoring in manufacturing of biologics), and Level 3 digital twins (e.g., closed loop fed batch bioreactor model predictive control, MPC) to support process design, control strategy identification, and advanced process monitoring & control. This role has accountability for delivering high quality process modelling solutions to project teams in large molecule drug substance so that our products are robustly developed, sources of variation are diagnosed, and process robustness is ensured and verified. In addition, a key component 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 the core areas of process simulation, MSPM and MPC. Additionally, the job holder is accountable for oversight of activities performed by external partners in modelling and leadership of external advocacy and collaboration activities. Key Responsibilities Provide strong technical leadership to their direct reporting line that ensures that the process modelling vision, strategy and objectives for large molecule drug substance are clear, a plan is in place to achieve and that stakeholders/sponsors are supportive. Drive implementation of advanced modelling approaches (such as system modelling, MPC) 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 Process Modelling and Digital Twin capability. 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. Ensure that modelling solutions are used to deliver robust control strategies for BLA 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 Global Manufacturing to deliver modelling solutions more efficiently. Prioritize and manage modelling software budgets, working closely with Tech and software suppliers to ensure modelling 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 potential by providing coaching, mentoring, and appropriate learning opportunities for all team members. Support cross-modality development of team members. Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree in Chemical Engineering or a science/engineering degree 8+ years of experience in modelling and/or pharmaceutical process development Experience using modelling and digital twins in process design, control strategy identification and advanced process monitoring & control Experience in people leadership Experience in product development and progressing medicines to the market Preferred Qualifications: Strong people leader to engage, motivate and develop a team of technical professionals Highly effective interpersonal, organizational and communication skills for working in a multi-disciplinary high-paced scientific team environment Deep passion & appreciation of using modelling and predictive tools in experimental design and demonstrated experience of delivering innovative modelling solutions Recognized as a technical expert internally and externally in their area of expertise Courage to lead and make difficult decisions Knowledge of Quality by Design (QbD) principles and their application Ability to coach and mentor team members #LI-GSK Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. 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