Lia Lor

• Oversee the Analytical Research and Development Department which includes staff trainings and developments, project reviews, manages ANDA submission data and processes.
• Schedules/ analyzes/ data reviews analytical testing of Raw Materials/ In-process/ Finished Products/ Stability for all projects, including controlled Substances (CI-CIV).
• Prepares/ reviews/ performs/ creates validations/verification studies and reports of analytical test methods, analysis, and other studies per FDA guidance.
• Performs/ prepares/ reviews laboratory investigations and reports.
• Prepares/ reviews document change controls for new and revision of in-house test method, specification and SOP.
• Manages, guides and trains Scientists/Chemists on methods, processes, procedures and equipment.
• Comprise PDR and QOS for assigned R&D projects
• Complies and interprets results of tests and analysis
• Reviews MDS (Material Data sheets)
• Assists Regulatory Compliance Department with submissions, annual product reviews and other investigations
• Assists QC Department with Trouble-shooting methods and instruments
• Conducts and supports Product Transfer from ARD to QC
• Coordinates with contract laboratories for outsourcing

▪ Performed routine analytical laboratory testing for Finished Product, Stability and Raw Materials using HPLC, GC, UV/Vis, FTIR, Dissolution, Particle Size analyzer (Horiba), TLC, wet chemistry, auto and manual titration

▪ Working knowledge of cGMP, SOP, USP, EP, BP and in house methods

▪ Trained new chemists on all aspects of the lab

▪ Helped design and implement the team concept, leading to 50% increase in productive within 3 months

▪ Supervised a team of 7 chemists, including delegation of work

▪ Worked with Empower, Turbochrom and ChemStation software

▪ Performed preventive maintenance on HPLC on a monthly basis

▪ Worked with the automation dissolution robot

▪ Documented, analyzed, and reported data

▪ Performed data and documentation review of laboratory analysis