Position Summary

The Associate Director / Principal Scientist of CMC Clinical Supply Chain will be responsible for small molecule CMC projects in terms of quality, quantity, timelines and other logistics for drug substance (DS) and drug product (DP) manufacturing to ensure reliable, compliant, cost effective, and on-time delivery of IMPs (Investigational Medicinal Products) for clinical trials in accordance with all related regulations and policies. Additionally, he/she will be a Person-in-Plant (PIP) to coordinate CMC activities to ensure high quality documentation with cGMP requirements.

Essential Duties And Responsibilities

Communicate with external partners and/or manufacturer sites to manage supply chain activities to meet clinical trial requirement.

 Act as Person in Plant (PIP), closely monitor CROs or CDMOs for cGMP manufacturing of DS and DP as well as labelling, packaging and shipping. 

Work closely with CMC team to plan DP qua...