The primary function for this position is to oversee analytical development’s daily activities, such as method development and validation, analytical testing and stability program.
- Supervise a group of analytical development scientists, and give guidance in their method development and validation, analytical testing, process support, stability and product evaluation
- Review method validation plans and reports to assure that the methods meet requirements during different phases of product development.
- Direct activities and design experiments toward troubleshooting/optimization of existing analytical methods when necessary.
- Assure accurate and timely testing and reporting all results, issuing technical reports which include certification and validation data.
- Provide guidance on analytical investigations of abnormal results
- Work in collaboration with other departments, e.g. Process, Formulations, Regulatory Affairs, Production, Supply Chain, etc, to support timely new product development and submissions.
- Work with contract laboratories and collaborators.
- Participate in selection, evaluation and development of new personnel.
- PhD or Master Degree in Chemistry, Pharmaceutical Sciences or related fields. Master with over 8 years of experience and PhD with over 3 years of experience in the pharmaceutical analytical chemistry.
- Working knowledge of major analytical techniques. Ability to train scientists on new techniques.
- Strong experience with analytical development in pharmaceutical development, including method development, validation, stability and in-process control within CMC.
- Familiar with pharmaceutical industry regulations and NMPA/FDA/ICH guidelines
- Proven supervisory experience.
- Good analytical skills in sorting information, formatting directions and problem solving.
- Good communication skills and English language ability.