Traci Savall

Background

About Traci Savall

Creative, team-oriented professional with a proven pharmaceutical industry record delivering new compounds from declaration to first in human clinical trials through to commercialization. Demonstrated expertise in all areas of drug product development; utilizing internal as well as external resources. Leadership/Team Work Lead cross functional project teams to consistently deliver on aggressive timelines Selection and management of Contract Research Organizations/Manufacturers (CRO/CRM) Technical transfer of processes; analytical methods and manufacturing from pre-clinical to clinical trial material (CTM) to commercial. Orchestrate scale-up, registration and validation activities of clinical trial and commercial materials Authored Regulatory submissions including CMC sections for IND’s, BLA’s, NDA’s and annual reports Scientific / Technical Skills Expertise in formulating and characterizing solid dosage forms (tablets, capsules, soft gels), topicals and IV (solution and lyophilized) formulations for clinical trial and commercial use Development of pre-clinical and toxicology formulations Design and implement ICH stability protocols for evaluation of formulations (solid, liquid, IV) and packaging configurations. Administrator for Stability Lab Information Management (SLIM) software system. Statistical analysis of stability data for establishment of expiration/retest dates. Physical characterization of small molecules using Thermal Gravimetric Analysis (TGA), Differential Scanning Calorimetry (DSC), Water Vapor Sorption/Desorption Analysis, Microscopy and Powder X-ray Diffraction (pXRD). HPLC method development, qualification, and validation. Experienced in purification and identification of peptides and small molecules by Mass Spectroscopy (electrospray), and HPLC (analytical and preparatory).