Associate Principal Scientist – Process Analytical Technology and Chemometrics

Google Chrome Microsoft Edge Apple Safari Mozilla Firefox Associate Principal Scientist – Process Analytical Technology and ChemometricsFull-timeCompany DescriptionEurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client' site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!Job DescriptionHigh Level Accountabilities:As an Associate Principal Scientist, you will provide expert support to continuous manufacturing of commercial products. Your knowledge in PAT, analytical science and technologies will be crucial in ensuring efficient and effective support to internal and external manufacturing sites and testing laboratories located in multiple countries.Description of Job Responsibilities; Typical and Specific accountabilities:Responsible expert for the delivery of PAT (instrument, chemometrics, and process control) support for on-market commercial products.Responsible for the framework lifecycle management of chemometric models related to the commercial supply or testing of drug products, ensuring equivalency for multi-site models.Management of products knowledge throughout the product lifecycle to enable robust PAT/model use and control strategies.Identifies opportunities and implements use of PAT to develop process understanding and evolve control strategies, including integration with commercial processes (in-line, on-line, at-line) to deliver business benefits.Provides support for model updates and validation in the on-market space.Provides technical expertise and leadership to aid in the resolution of PAT instrument/model-related manufacturing issues and complaints impacting supply, including application of multivariate analysis.Develops suitable corrective and preventive actions in support of PAT and/or chemometric model related investigations.Responsible for the support of impact or transfer of PAT methods (including chemometric model) in relation to asset strategy projects internally or to external manufacturing partners.Takes leadership in developing, maintaining, and collaborating with instrument vendors (including software) and model software vendors to support changes, improvements and issue resolution.Defines business strategy for the integration of PAT/MSPC in the on-market space.Leads stakeholder engagement and builds business cases for implementation of new PAT technologies in the on-market space.Leads, assesses impact & supports complex technical improvements or change activities assuring product performance.Knowledgeable of vibrational spectroscopy methods and Process Analytical Technology (PAT) applications and provides support to associated models during development and routine use phases.Supports the development of models used in the application of improving product robustness – including process performance monitoring, process performance predictive modelling, real-time or near real time models, etc. via methods such as MSPC (multivariate statistical process control).Identifies opportunities for model improvements and digital innovation.Using domain-specific understanding, translates unstructured, complex business problems into the appropriate data problem, model and analytical solutions.Researches and develops advanced predictive models and computational methods to guide and shape decision-making within the project scope.QualificationsEssential Skills/Experience:Ph.D. – 5+ years, MS – 8+ years, BS – 10+ years of...