Singapore
- Lead Process Development - Commercial Attribute Sciences organization at Amgen Singapore Manufacturing. - Strategic planning and technical oversight of analytical testing and forensic analyses. - Drive product attribute understanding and support for commercial and clinical biological and synthetic drugs' campaigns. - Collaborate with partners from different functions at site and global levels.
- Manage a team of associate scientists. - Product stewardship lead (analytics) of a biosimilar program: lead global method transfer, regulatory submission, audit, etc. - Member of site extended leadership team. - Provide technical support for raw material, in-process, release and stability testing of biological and synthetic drugs. - Provide technical support for the investigation of problems related to product attribute, analytical testing and manufacturing process. - Involved in method development, qualification, improvement and transfer. - Set up laboratory and analytical testing capability in Process Development team. - Appointed as the safety risk assessment team leader, safety committee and compliance team member. - Experienced in HPLC/UPLC (AEX, CEX, SEC, ALC, HILIC Glycan, RPLC, HIC, FIA), LCMS, headspace GC-FID, UV-Vis spectrometer, reduced and non-reduced CE-SDS, cIEF, PCR, ELISA. - Experienced in Empower and Chromeleon CDS.