This role is to do process development and optimization for CMC development of early phase drug substance to achieve on-time delivery of materials and cost competitive synthesis, scale up manufacture, as well as writing synthesis/process related documents.
Responsibility:
? Perform API/RSM/SM manufacture process development in synthetic lab, and scale up in kilo-lab, to achieve on-time delivery for early phase projects including pre-clinical and clinical batches.
? Drive process development for robustness, cost competitiveness, lead-time control, and full compliance.
? Comply all EHS requirements, and timely communicate with EHS and other relevant team to improve lab efficiency.
? Communicate and align with analytical, DP and API group, CMC-RA, QA, and finance & procurement.
? Support the drafting and compilation of HA filing package, annual report, and various communication package per project needs.
Requirement:
? A Ph.D. or master degree in organic chemistry related, and interested in process development in small molecule API within pharmaceutical industry.