Responsibilities:

1. Responsible for analytical method development and validation;

2. Responsible for conducting forced degradation studies, stress testing, and stability studies;

3. Responsible for establishing quality standards for starting materials, intermediates, drug substances/APIs, and drug products, and setting reasonable limits according to relevant guidelines;

4. Responsible for drafting regulatory submission documents related to drug analysis;

5. Responsible for tracking the experimental progress of clients/sponsors, reviewing study protocols, records, and reports; responsible for solving problems encountered during analytical testing;

6. Responsible for writing and reviewing analytical experimental records to ensure the timeliness and accuracy of analytical data;

7. Responsible for routine maintenance and care of analytical equipment;

8. Complete other tasks assigned by supervisors/management.

Qualifications:

1. Master’s degree or above; outstanding bachelor’s degree from key universities may also be considered; pharmacy-related majors preferred;

2. 8+ years of experience for bachelor’s degree holders, 6+ years for master’s degree holders; with complete project quality research and regulatory submission experience; including at least 2 years of quality research experience in peptide projects; experience in advancing multiple projects simultaneously is preferred;

3. Proficient in common analytical instruments such as HPLC and LC-MS; able to independently complete analytical method development and validation;

4. Familiar with pharmacopoeias and regulations including ICH, ChP, EP, and USP;

5. Certain ability in English literature reading and oral expression;

6. Proficient in office software;

7. Hardworking, positive and rigorous work attitude, strong sense of responsibility, good teamwork spirit, and good job stability.