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.

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.

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.

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.