- Direct a group of analytical development scientists, and give technical guidance in their method development and validation, analytical testing, process support, stability and product evaluation. Provide guidance on analytical investigations such as OOS and atypical results.
- Develop analytical development strategy of drug substance and drug product to meet requirements during different phases of product development.
- Direct method transfer activities to CROs and CMOs or other organizations.
- Recommend approval of specifications for raw materials, in-process control, API, finished drug product and stability testing.
- Direct activities in CMC submissions. Coordinate the activities toward answering regulatory agency’s CMC deficiency responses.
- Work in collaboration with other departments, e.g. Process, Formulations, Regulatory Affairs, Production, Supply Chain, etc, to support timely new product development.
- PhD or Master degree in Chemistry, Pharmaceutical Sciences or related fields. Master with over 15 years of experience and PhD with over 10 years of experience in pharmaceutical analytical chemistry.
- Strong experience with analytical development in pharmaceutical development, including method development, validation, stability and in-process control within CMC.
- Well versed with current analytical techniques.
- Thorough knowledge of pharmaceutical industry regulations, and very familiar with FDA/ICH guidelines.
- Proven record of supervisory and project management experience.
- Overseas education and working experience is preferred.
- Strong analytical skills in sorting information, formatting directions and problem solving. Logical thinker and quick learner.
- Good communication skills and positive interpersonal skills.
- Good reading and writing in English,. Good oral English communication is a plus.