Research - Gainesville, Florida, United States
• Supply chain and Optimization of purchasing processing• Design, validation and implementation of microbiology methods• Laboratory design, start-up and qualification• Design of daily lab operations• Investigations of microbial excursions, presence of objectionable organisms and out-of-specification findings• Laboratory optimization and management• Laboratory design, qualification, optimization and automation• Microbial identification strategies SOP and protocol development• Method validation and process technology transfer- Scale up and Scale down process• Risk assessments (e.g., objectionable organisms, microbial data deviation, bioburden excursions)• Failure investigations and root cause analysis• Scale up and scale down microbial/fermentation process• Early-stage, mid and late stage process development design• Nonclinical CRO/CMO/CDMO selection and oversight support• Evaluate the existing synthetic route and identify the steps that may cause problems during scale-up manufacturing• Process improvement based on the concept of Quality by Design (QbD)• Search for reliable suppliers for key starting and raw materials• Design process optimization - Safe and robust processes• Process and DS cost optimization studies• Microbial strain selection and characterization, media development