• Experienced in continuous manufacturing regulatory CMC requirements.

• Design and oversee the execution of development plans to support DMF and ANDA submissions for 3 pipeline projects.

• Facilitate quality risk assessment, process characterization, and control strategy development with cross-functional collaboration.

• Ensure technical alignment through tech transfers across scale.

• Lead multifunctional team in drug substance process development on batch and continuous manufacturing process for a small molecule active pharmaceutical ingredients (API).

• Design integrated continuous manufacturing process and equipment using process analytical technologies (PAT), automation, and innovative engineering solutions.

• Manage the design, procurement, installation, and commissioning of an integrated continuous drug substance pilot plant.

• Lead P&ID, equipment and instrument specification and control system design for end-to-end production of a small molecule API that include solvent/reagent feed tanks, raw material dissolution, continuous stirred tank and plug flow reactors, membrane separation, thin-film evaporation, mixed suspension–mixed product removal (MSMPR) crystallization, continuous filtration and drying.

• Design start-up, shutdown, cleaning strategies and procedures. Draft and review Technical Transfer Documents, Sequence of Operations and Engineering Protocols.

• Manage external equipment vendors, material suppliers and contractors.

• Perform design of experiments (DOE) for process characterization, PAR setting. Build empirical models with traditional DOE analysis and Bayesian regression for robustness evaluation.

• Apply data science and artificial intelligence in process development including property prediction, analytical/reaction condition/reagent recommendation and reaction optimization.

• Utilize and evaluate Process Analytical Technology (PAT) tools for process understanding and build mechanistic models.

• Develop chemical process for small molecule active pharmaceutical ingredients (API) and intermediates.

• Process invention and unit operation optimization. Process modeling of equipment fit, mixing, heat transfer and crystallization evaluation.

• Prepare technology transfer documents to external manufacture network and oversee campaign production.

• Perform high-throughput experimentation for categorical variable, solubility and crystallization screening.

• Evaluate and develop membrane reactor and separation processes in active pharmaceutical ingredients production.