Chi-Li Chen Email & Phone Number

Cambridge, MA, US

San Francisco, California, US

San Francisco, California, US

• Led CMC drug substance efforts for the THB001 and THB335 programs, focusing on process development and manufacturing at external CDMOs, delivering multiple toxicology and GMP campaigns for program development.
• Conducted process development to enhance purity, scalability, and cost efficiency, while performing risk assessments for mutagenic impurities and optimizing impurity control in manufactured batches.
• Drafted CMC sections for regulatory submissions (IMPD, IND) supporting key filings and regulatory compliance.

• Led CMC drug substance efforts for the CAD-9303 and CAD-1883 programs, advancing them from preclinical stages to Phase 1-2, delivering impurity-enriched toxicity batches and high-purity GMP batches.
• Oversaw technology transfer to CDMOs, optimizing processes for yield, purity, and scalability, and developed crystallization protocols for stable polymorphs while controlling impurities.
• Contributed to IND M2 and M3 sections for Phase 1-2 development.
• Supported CMC diligence for successful fundraising and acquisition by Novartis.

Watertown, MA, US

• Completed 15 fee-for-service projects in CRO/CDMO settings, successfully scaling up multiple molecules for drug candidate nomination.
• Led the development and scale-up of regulatory starting materials in-house while transferring technology to CDMOs for multi-kilogram production and toxicity batch manufacturing.
• Collaborated with a CDMO during pre-formulation to enhance the solubility and stability profiles of lead molecules.
• Gained extensive experience handling high-potency APIs (HPAPI) through program management, manufacturing campaigns, and collaboration with CDMOs and consultants.

• Developed a new synthetic approach for a key building block of solithromycin and optimized the synthesis of the desosamine donor, successfully delivering multi-hundred grams in-house.
• Scaled up and delivered major building blocks to support internal development, managing the optimization and production at a CDMO.

Watertown, Massachusetts, US

• Process Development and Manufacturing: Led the process development and manufacturing of Eravacycline, which received FDA approval in August 2018.
• API Crystallization: Conducted process R&D and polymorphism studies for crystallization of the API, delivering products for Phase II-III trials while supporting Quality by Design (QbD) initiatives and registration.
• Regulatory Starting Material: Developed a new synthetic route for regulatory starting materials, successfully delivering products to support Phase II-III trials, as well as registration and validation batches.
• Developed and delivered 2 kg of TP-1656 in-house to support the manufacture of TP-2758 for Phase 1 clinical trials.
• Managed external production campaigns, overseeing technology transfers to CDMOs in the US, China, and Europe, and ensuring successful scale-up from 100 g to 80 kg of final product.

Watertown, Massachusetts, US

Watertown, Massachusetts, US

• Advisor: Professor Yoshito KishiDeveloped methodology and completed formal synthesis:
• Developed a stereospecific Ireland-Claisen rearrangement, used to complete the formal synthesis of the H and I rings of halicondrin B in 23 steps, delivering 7 g of the final product.
• Optimized the Katsuki epoxidation process to synthesize the C14-C20 fragment of mycolactone, delivering over 100 g of the building block.

• Advisor: Professor Stephen F. MartinDeveloped methodology and completed total synthesis:
• Completed the total synthesis of Vineomycinone B2 Methyl Ester, utilizing an intramolecular double benzyne-furan cycloaddition with silicon tethers.
• Developed a Pd-catalyzed ring-opening reaction and oxidation process for synthesizing C-aryl glycosides, 2-substituted 1,2-dihydro-1-naphthols, and 2-substituted 1-naphthols.

Phd, Synthetic Oranic Chemistry

Bs, Chemistry