Amanda Merolla Email and Phone Number

All activities are conducted in compliance with the Food and Drug Administration Good Laboratory Practice Regulations for the purpose of ensuring the quality and integrity of the test articles.Receipt, storage, inventory, and distribution of test article for non-clinical purposes.Formulation of oral formulations for safety evaluations.Formulation of IV, Subcutaneous, and IM formulations using aseptic techniques for safety evaluations.Experience working with BSL-1 and BSL-2 material.Coordination of dose form assay samples for analysis in RLIMS.Shipment of test articles between global non-clinical laboratories, including contract laboratories.Maintenance and distribution of test article information to biologists, chemists, study directors, and project coordinators.Taking of reserve samples as per SOP and protocols.Maintenance and distribution of test article stability memos.Lead of a select team that assesses a test articles Maximum Feasible Concentration (MFC) for different dosing apparatus. Lead for staff and laboratory workload scheduling.Interviewing and selection of new staff.Training of new and cross-training staff.Sourcing and ordering of commercial compounds, excipients and supplies.Liason for FDA audit responses.Provide support as the lead point of contact for the Central Pharmacy for Xybion's Pristima after the installation and subsequent upgrades of the system.Author SOPs.Lead in the revision of the test article section of the study method report template.