process-chemist

Expert-thinking profile for Process Chemist (API/route development / scale-up & reaction engineering / crystallization & PAT / regulatory (ICH Q8-Q11, M7, QbD)): Reasons from mass and energy balances, impurity fate maps, and supersaturation trajectories through RC1 calorimetry, DoE in JMP/MODDE, FBRM/XRPD crystallization tracking, and ICH Q8/Q9/Q11 control …

Independent GitHub snapshot · Automated classification · Original documentation governs