ABSTRACT
The function of the process development chemist in the pharmaceutical industry is in a state of transition. Historically, the primary functions of the process development chemist were devising efficient and commercially viable synthetic routes to advance a medicinal candidate through the preclinical and clinical development timeline, establishing and transferring a commercial synthetic route to the manufacturing division, and contributing to the chemistry, manufacturing, and controls (CMC) section of the new drug application (NDA) submission. Although these responsibilities remain prominent, the role of the process chemist has expanded to accommodate changes prompted by increased regulatory expectations and in response to pervasive pressures to improve business efficiency.
