Developing, validating, troubleshooting methods for raw materials, IPC, final product, stability study, and cleanout samples, for API, and non-API products all under cGMP.

Key responsibilities:

1. Developing, validating, troubleshooting methods for raw materials, IPC, final product, stability study, and cleanout samples, for API, and non-API products all under cGMP.
2. Writing, executing protocols and validation analytical methods to prove methods are suitable for intended use based on ICH and USP/EP requirements to support API lifecycle from early development to clinical stages and registration.
3. Effective coordination with customer for development, manufacture, release of product for new drug evaluations (NDEs) by supporting analytical aspects of project to meet project timelines.
4. Working with stakeholders (Regulatory Affairs, EH&S, process chemists, process engineers) to optimize methods and process and to establish appropriate specifications for raw material, in-process control and final release testing.
5. Promote active scientific knowledge exchange and work in a collaborative manner with other group members to facilitate the smooth progress of ongoing projects.
6. Perform analytical instrument/method troubleshooting in the lab.
7. Maintain lab notebook under cGMP guidelines.
8. Writing lab SOPs, CCR, CAPA, QI, LIR, OOS, OOT, NL.

• 0-4 years of related experiences in pharmaceutical industry, preferably in CDMO. Good knowledge of general analytical chemistry and chromatography in the characterization of small molecule APIs.
• Working knowledge of ICH guidelines and other regulatory guidelines (such as FDA, EMA, etc.).
• Ability to solve analytical problem and propose innovative solutions independently.
• Good communication skills, both oral and written. Good working habit in observance of EHS guidelines and comply with corporate policies. Collaborate effectively and efficiently with interdisciplinary working group/project team members.