岗位概述：
Contribute to internal and external CDMO analytical development relevant activities in support of drug substance (DS), drug product (DP) process research, formulation development, quality control, stability study, etc.

MAJOR ACCOUNTABILITIES/岗位主要职责：
1. Execute method development/validation/transfer, stability study and release from early to late-stage drug development.
2. Design, plan, perform, interpret and report results of scientific experiments for starting material, intermediates, DS and DP.
3. Works closely with internal partners and external CDMOs to ensure timely and quality analytical deliverables.
4. Participate in the authoring of CMC sections of the clinical trial applications (IND/IMPD/CTA) and/or marketing applications (NDA/MAA).
5. Contribute to ARD setting, maintain infrastructure/instrument, ensure ARD lab daily operation excellence.

Experience/经验要求 ：
Master with at least 1+ years’ experience in pharmaceutical analytical science, analytical chemistry, or pharmacetical science.

Specific skills/技能要求：
1. Familiar with multiple analytical technology, include but not limited to HPLC/UPLC, GC, Dissolution, etc.
2. Analytical experience in innovator or generic drug development and show strong capability on DS, DP analytical development work is highly desirable.
3. Basic understanding of GMP and regulatory.
4. Experience in method development/validation/transfer and stability study.
5. Basic scientific/technical writing skills
6. Basic scientific and business communication skills (both verbal and technical) and interpersonal skills are required.