Lead a team of data scientists and business analysts to deliver insights and analytics solutions to the Global Product Development and Supply (GPS) organization, focusing on Product Development (PD).Deliver data-driven insights and recommendations to senior executives within the GPS leadership team.Inform long-range planning and strategic investment decisions.Develop forecasting and planning analytics to inform clinical supply planning and manufacturing, CMC asset strategy, budget, and resource allocation across a diverse product development portfolio.Define, measure, and report KPIs for the Product Development organization to drive continuous improvement.

Lead matrix CMC teams for assets from pre-clinical development through lifecycle management.Lead the development and execution of an integrated GPS strategy that meets clinical and commercial objectives.Represent CMC and clinical supply planning as a core member of the Global Program Team. Accountable for managing program budget and resource allocation, including endorsement of program strategy and corresponding resources through appropriate governance interactions.Responsible for program risk management, including escalation to key stakeholders within PD and Global Drug Development (GDD).Ensure seamless execution of clinical supply strategy, including comparators, for all clinical studies.Mentor matrix team members and collaborators by providing candid and actionable feedback, identifying development opportunities, and providing the resources needed to be successful in stretch assignments.

Lead drug substance development teams for small molecule assets from pre-clinical through launch. Experience leading assets through global regulatory submission and approval. Responsible for drug substance sections of Module 3 of NDA/MAA and response to all drug substance RFIs from global health authorities.Accountable for the design and implementation of drug substance manufacturing processes that are safe, robust, sustainable, and cost-effective. Experience leading large matrix teams and managing Contract Development and Manufacturing Organizations (CDMOs).Responsible for defining the drug substance book of work and managing project timelines and resources and budget.Manager of people.

Lead project team of organic chemists, analytical chemists and chemical engineers to deliver drug substance manufacturing processes for small molecule APIs. Includes oversight of development efforts conducted by external partners.Accountable for technology transfer of drug substance manufacturing processes to external manufacturing sitesEngineering lead supporting drug substance process development for programs from pre-clinical through commercial launch

Chemical engineer working in pharmaceutical process development.Coordinate studies across a diverse project team of chemists and engineers to ensure development timelines are met.Work with external vendors and suppliers to achieve scale-up of specialty chemical processes.Conduct lab studies to support process development and scale-up as well as regulatory submission.Develop modeling and analysis techniques to support data-based decision-making.

- Graduate researcher in the group of Dr. Marianthi Ierapetritou- Project coordinator for Project D5 within the Engineering Research Center for Structured Organic Particulate Systems- Conduct flowsheet modeling of continuous pharmaceutical processes using gPROMS- Apply global sensitivity analysis methods to continuous pharmaceutical tablet manufacturing processes- Implement data-based and reduced-order modeling methodologies for particulate processes- Develop methods for surrogate-based feasibility and flexibility analysis- Assist in grant and proposal preparation- Supervise and mentor undergraduate and Masters students conducting research in the area of Process Systems Engineering

- Conduct lab studies to support process development, increase process knowledge and expand design space- Develop modeling and automation technologies to support department-wide productivity initiatives - Provide development and documentation support for pilot plant campaigns - Support technology transfer of pharmaceutical process to manufacturing site in Dublin, Ireland- Familiar with composing and reviewing GMP documentation

- Conducted experiments and collected data in order to determine rates of simultaneous reactions- Modeled reactions in DynoChem and estimated kinetic parameters- Optimized reaction conditions for maximum yield and minimal side reactions- Presented project findings to department managers

Publication: Book Chapter “Nanotechnology based Delivery Systems” in Biomedical Nanostructures, published by John Wiley and Sons. Coauthored with Dr. Xiaojun Yu, Chandra M. Valmikinathan and Junping Wang Role and Responsibilities:- Designed and implemented procedures for the preparation of protein loaded nano and micro particles from hydrophobic and hydrophilic polymers- Characterized size, morphology and release profiles of protein loaded micro and nano particles