Patti Haller
About Patti Haller
Patti Haller serves as the Senior Director of Technical Operations CMC at Travere Therapeutics, bringing extensive experience in pharmaceutical operations and regulatory compliance. She holds a Ph.D. in Chemical Engineering from Cornell University and has worked in various roles across the industry, including positions at Bachem and Skyepharma.
Work at Travere Therapeutics
Patti Haller has been serving as the Senior Director of Technical Operations CMC at Travere Therapeutics since 2019. In this role, she oversees various aspects of technical operations, focusing on the development and manufacturing of pharmaceutical products. Her responsibilities include ensuring compliance with regulatory standards and managing the technical aspects of drug development processes.
Previous Experience at Bachem
Prior to her current role, Patti Haller worked at Bachem as the Director of Operations and Planning from 2015 to 2019. During her four years in this position, she was responsible for overseeing operational strategies and planning within the organization, contributing to the efficiency and effectiveness of production processes in the Greater San Diego Area.
Educational Background in Chemical Engineering
Patti Haller holds a Ph.D. in Chemical Engineering from Cornell University. She also earned a Master of Science in Chemical Engineering from The Johns Hopkins University and a Bachelor of Science in Chemical Engineering from Carnegie Mellon University. Her educational background provides a strong foundation for her expertise in the pharmaceutical industry.
Expertise in Pharmaceutical Operations
Patti Haller has extensive experience in managing critical regulatory documents such as Drug Master Files (DMF), Investigational New Drug applications (IND), New Drug Applications (NDA), and Master Batch Records (MBR). She is knowledgeable in chemical synthesis and purification techniques, including tangential flow filtration, RP-HPLC, SEC, and IEX chromatography, which are essential for pharmaceutical development.
Regulatory Knowledge and Risk Management
Patti Haller possesses in-depth knowledge of regulatory frameworks, including FDA regulations, ICH guidelines, USP, and EP. She specializes in process validation and risk management, utilizing methodologies such as Failure Modes and Effects Analysis (FMEA). Her expertise in CAPEX planning and contract negotiation further supports her role in the pharmaceutical industry.