Solid form selection for API, intermediates and starters

Route / process selection utilizing high throughput process parameter screening techniques

Isolation design utilizing high throughput solubility assays, polymorph and salt screens 

Master Batch Record and Change Control document review and sign-off

Excursion management (Deviation, Investigation, OOS etc.) document review and sign-off

Excursion management (Deviation, Investigation, OOS etc.) document review and sign-off

Design of experiments with parameter ranges for process characterization / risk assessment activities

Identification and synthesis of impurities (in-process, degradants, nitrosamines) for purging studies / purge factor analyses (Mirabilis)

Implementation of green chemistry principles to process development / manufacturing

Apply PMI metrics to manufacturing processes throughout the development lifecycle in order to assess process improvements and efficiency