Key Responsibilities:

• Conduct literature research on synthetic routes for internal candidate compounds; compile research plans and develop route exploration strategies.

• Develop robust manufacturing processes for APIs, ensuring process robustness; investigate potential impurities and polymorph control to ensure product quality meets ICH and relevant domestic/international regulatory requirements.

• Prepare samples from gram to hundred‑gram scale to ensure timely material supply for early non‑clinical studies.

• Comply with laboratory daily management regulations and maintain timely and accurate experimental records.

• Execute technology transfer of API processes; guide CDMOs in pilot‑scale production, as well as toxicology batch and GMP batch manufacturing.

• Oversee the entire process development and production lifecycle in accordance with regulatory requirements for new drugs, ensuring that API process development and manufacturing are fully compliant with clinical study requirements.

• Collaborate closely with key raw material suppliers to ensure uninterrupted material availability.

• Systematically organize process development and production data; draft R&D reports and patent documents as required.

• Compile and review regulatory submission dossiers.

Qualifications:

• Master’s degree or above in Organic Chemistry, Medicinal Chemistry, or a closely related field.

• At least 6 years of experience for Master’s candidates, or at least 2 years for PhD candidates, in API process development and production; experience with or collaboration with CRO/CMO organizations is preferred.

• Solid knowledge of organic chemistry and strong process development capabilities, with proven ability to solve diverse problems arising during process development.

• Basic knowledge of GMP and familiarity with domestic and international new drug registration regulations and requirements.