Job Description
1. Experienced in parental formulation analysis and new modality analysis (especially oligo and mass spectrometry).
2. Able to handle regulatory inspections from FDA, EMA. CFDA etc and GMP audits and from clients as well as internal quality assurance unit
3. Provide technical guidance/direction to the team as well as evaluate new analytical technologies to enhance department capabilities
4. Play a role in critical and major technical or quality related issue detection and associated trouble-shooting and investigation.
5. Involve to assist solving key technical and quality issues as requested by the team.
6. Experienced in team and project management.
Qualification
1. Ph.D. degree or equivalent in Analytical Chemistry or other directly related science discipline with pharmaceutical industry experience of no less than 8 - 10 years in Analytical R&D/Quality Control laboratory function
2. Proven good track record of accomplishments in the Analytical R&D and CMC development area - managing different phases of new drug development program and launching new products in major global markets desirable.
3. Fluent oral English communication skill.