职位描述:

1.Responsible for analytical aspects of drug substance/product development, including analytical method development, validation and implementation, specification establishment, technology transfer, aberrant investigation, etc.

2.Collaborates closely with Discovery, Process, Formulation, QA, Regulatory, ESH and other functions

3.Leads and manages an experienced team of analytical chemists

4.Authors, reviews, and approves technical reports and regulatory documents for IND or NDA projects

5.Effectively guides and manages external collaborations

任职条件:

1.PhD in analytical chemistry or related discipline with 5+ years of pharmaceutical industry experience

2.Experienced in analytical method development and validation is essential, IND or NDA package preparation is a plus

3.Proven skills in analytical method and instrumentation problem solving

4.Knowledgeable in cGMP, USP, ICH relevant guidelines