Applied chemometrics expertise:• SME for PAT and chemometrics on CDC line development.• Lead chemometrics support for On-Market commercial products.• Employed modeling methodologies to gain process understanding, improve product robustness, and drive business benefits.• Owner and SME of an Artificial Neural Networks (ANN) model supporting a flexible formulation and leading its transfer to external manufacturing partners enabling a successful product divestment.• Played a… Show more Applied chemometrics expertise:• SME for PAT and chemometrics on CDC line development.• Lead chemometrics support for On-Market commercial products.• Employed modeling methodologies to gain process understanding, improve product robustness, and drive business benefits.• Owner and SME of an Artificial Neural Networks (ANN) model supporting a flexible formulation and leading its transfer to external manufacturing partners enabling a successful product divestment.• Played a pivotal role in defining technical standards, staying updated on the latest developments in chemometrics technologies, and providing training ensuring compliance with AZ and external regulatory policies• Oversaw the maintenance and troubleshooting of Raman PLS models, ensuring accurate prediction of content uniformity. • Conducted in-depth investigations into model results, taking accountability for addressing and resolving any issues. • Responsible for the re-development of models that require major updates to maintain model performance. Show less

Strategic Chemometric Modeling Leadership:• Worked with internal and external experts to improve modeling software products.• Provided guidance on the generation of relevant experiments for the development of chemometric models.• Coordinated trainings and real-time support to expand the use of chemometrics modelling across the company sites.Innovative Model Development and Implementation:• Developed chemometric models to extract critical information from process time… Show more Strategic Chemometric Modeling Leadership:• Worked with internal and external experts to improve modeling software products.• Provided guidance on the generation of relevant experiments for the development of chemometric models.• Coordinated trainings and real-time support to expand the use of chemometrics modelling across the company sites.Innovative Model Development and Implementation:• Developed chemometric models to extract critical information from process time series data for a large molecule downstream process to enable continuous manufacturing.Team Empowerment and Expansion:• Played a pivotal role in upskilling new team members and project teams in the effective use of chemometric models, coordinating trainings, and providing real-time support across company sites.• Led the recruitment of Chemometricians and mentored team members to ensure their success in modeling-related responsibilities. Show less

Subject Matter Expert (SME) in PAT Support:• Provided Process Analytical Technology (PAT) support for diverse assets during process development and played a key role in defining control strategies, contributing to improved operational efficiencyInnovative Analytical Tool Development:• Advanced the delivery of analytical tools, particularly for low dose formulations, showcasing a commitment to innovation and enhancing formulation processesPAT Capability Enhancement:•… Show more Subject Matter Expert (SME) in PAT Support:• Provided Process Analytical Technology (PAT) support for diverse assets during process development and played a key role in defining control strategies, contributing to improved operational efficiencyInnovative Analytical Tool Development:• Advanced the delivery of analytical tools, particularly for low dose formulations, showcasing a commitment to innovation and enhancing formulation processesPAT Capability Enhancement:• Successfully delivered PAT capabilities essential for comprehensive process understanding and control strategy, including feeder monitoring and feed-frame monitoring.• Developed spectroscopic chemometric models during process development for a continuous tablet line, contributing to streamlined operations and quality improvement. Show less

Continuous Manufacturing Process Enhancement:• Successfully executed the initial transfer activities for chemometric models developed for a continuous manufacturing line, ensuring a smooth transition and maintaining model accuracy.• Established critical limits for statistical parameters during the commercial phase of a continuous process, enhancing process control and product quality.• Played a key role in the conversion of existing products from batch to continuous manufacturing… Show more Continuous Manufacturing Process Enhancement:• Successfully executed the initial transfer activities for chemometric models developed for a continuous manufacturing line, ensuring a smooth transition and maintaining model accuracy.• Established critical limits for statistical parameters during the commercial phase of a continuous process, enhancing process control and product quality.• Played a key role in the conversion of existing products from batch to continuous manufacturing processes, contributing to increased efficiency and productivity.Strategic Decision-Making and Implementation:• Actively participated in decision-making processes, formulating both short and long-term strategies for the implementation of continuous manufacturing processes in a pharmaceutical plant, driving plant-wide improvements. Show less

Advanced PAT Integration for Continuous Manufacturing:• Conducted feasibility studies and successfully developed chemometric models to predict drug content in powder blends and tablets during continuous manufacturing.• Implemented qualitative and quantitative chemometric models using NIR for real-time monitoring, enabling effective in-process control and contributing to Real-Time Release Testing (RtRT).Strategic Model Identification and Technical Documentation:• Developed a… Show more Advanced PAT Integration for Continuous Manufacturing:• Conducted feasibility studies and successfully developed chemometric models to predict drug content in powder blends and tablets during continuous manufacturing.• Implemented qualitative and quantitative chemometric models using NIR for real-time monitoring, enabling effective in-process control and contributing to Real-Time Release Testing (RtRT).Strategic Model Identification and Technical Documentation:• Developed a strategy for the identification of powder blends as an in-process control tool, contributing to improved process monitoring.• Generated comprehensive technical documentation adhering to FDA, ICH, and EMEA quality guidelines, ensuring compliance and documentation excellence.• Played an active role in the preparation and submission of NIR chemometric models for blend and tablet analysis to the FDA, facilitating real-time release testing.Statistical Analysis and Operator Development:• Performed rigorous statistical analysis of chemometric data using tools such as Minitab, Excel, and SIMCA, ensuring precision in drug content.• Accountable for operator development by guiding and training them on NIR instrumentation and procedures, as well as interpreting chemometric models, fostering a skilled and capable team. Show less