# Guanghui Zhu

> CMC / Program Lead for Small Molecule API

Location: Greater Boston, United States
Profile: https://flows.cv/guanghui

Using project management and data science tools to drive drug development team performance, lower development cost, and improve speed to market.

## Work Experience
### Senior Staff Engineer @ Takeda
Jan 2022 – Present | Cambridge, Massachusetts, United States

### CMC Lead @ CONTINUUS Pharmaceuticals
Jan 2022 – Jan 2022 | Boston, Massachusetts, United States
- 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.

### Reaction Engineering Manager / Project Lead @ CONTINUUS Pharmaceuticals
Jan 2021 – Jan 2022 | Boston, Massachusetts, United States
- 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.

### Senior Scientist @ Bristol Myers Squibb
Jan 2021 – Jan 2021 | New Brunswick, New Jersey, United States
- 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.

### Research Investigator II @ Bristol Myers Squibb
Jan 2019 – Jan 2021 | Greater New York City Area
- 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.

### R&D Intern @ Alcon
Jan 2018 – Jan 2018 | Greater Atlanta Area
Study tear film deposition and interaction with contact lenses.
Develop standard method for fluorescent visualization of biomolecules using design of experiment method.
Digital image processing and statistical analysis on biomolecule deposition results.


## Education
### Doctor of Philosophy (Ph.D.) in Chemical Engineering
Georgia Institute of Technology

### Master of Science (M.S.) in Chemical Engineering
University of Maryland

### Bachelor of Science (BS) in Chemical Engineering
Shanghai Jiao Tong University


## Contact & Social
- LinkedIn: https://linkedin.com/in/guanghui-zhu

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Source: https://flows.cv/guanghui
JSON Resume: https://flows.cv/guanghui/resume.json
Last updated: 2026-03-31