- Responsible for analytical aspects of drug substance/product development, including analytical method development, validation and implementation, specification establishment, technology transfer, aberrant investigation, etc.
- Collaborates closely with Discovery, Process, Formulation, QA, Regulatory, ESH and other functions.
- Leads and manages an experienced team of analytical chemists.
- Authors, reviews, and approves technical reports and regulatory documents for IND or NDA projects.
- Effectively guides and manages external collaborations.
- Ph.D. in analytical chemistry or related discipline with 5+ years of pharmaceutical industry experience
- Experienced in analytical method development and validation is essential, IND or NDA package preparation is a plus
- Proven skills in analytical method and instrumentation problem solving
- Knowledgeable in cGMP, USP, ICH relevant guidelines
Fluency in Mandarin and English preferred
Please submit your resume and CV to Joanna.Zhao@Innocarepharma.com and mention that you saw this JD on the SAPA website.