Patrick Sneed Email & Phone Number

• Acting as a Subject Matter Expert (SME) for a test method validation remediation project• Acting Empower Administrator for the Test Method Validation group• Performing gap assessments on previous test method validations and determining if re-validation is required based on the company's Chemical Test Method Validation procedure• Performing pre-validation studies to determine if test methods are suitable for their intended purpose• Writing and executing validation protocols and writing validation reports• Training analysts on changes to test methods following validation• Coordinating validation activities with a contract lab by evaluating test methods, sourcing required testing materials, gathering pertinent method documentation, performing interviews with experienced analysts to identify opportunities for improvement, collaborating with multiple functional groups (i.e. QA, R&D, Manufacturing and the Contract Lab) to address potential issues and solutions for method validation and performing peer level QA reviews of method development reports, validation protocols and validation reports

• Developing analytical testing methods for the assay, content and blend uniformity, dissolution and related substances testing of pharmaceutical formulations under cGMP conditions • Writing method development reports and method validation protocols and writing and reviewing standard operating procedures (SOPs)• Training laboratory personnel on SOPs, regulatory guidelines, analytical testing methods and instrumentation

• Executing method validation protocols and writing method validation reports• Testing of finished product and stability samples• Ensuring regulatory compliance by performing a daily solutions check • Working with Waters and Agilent HPLC, Waters UPLC, Agilent and Shimadzu GC, Agilent and Perkin Elmer UV/vis and Hanson dissolution apparatuses

• Developing analytical High Performance Liquid Chromatography (HPLC) methods to perform testing on dietary supplements under cGMP conditions and food products• Developing auto-titration methods on a Lab Synergy Multi-T auto-titrator • Performing analytical tests on raw materials, intermediate and final product samples to ensure they meet internal specifications• Working with HPLC, UHPLC, ICP-OES, Auto-titrator and Lab Synergy Dumatherm protein analyzer• Writing SOPs and training personnel on SOPs and analytical test methods

• Developing analytical HPLC methods for active pharmaceutical ingredients (APIs) • Performing method validations for HPLC analytical methods under cGMP conditions• Performing standard qualifications under cGMP conditions• Running in-process and final product samples using a variety of analytical methods and techniques• Familiar with IR, HPLC, and GC instrumentation and basic lab equipment• Acting as project lead and running experiments to help develop multiple API manufacturing processes • Developing and writing standard lab procedures based on performed experiments• Writing process development reports• Overseeing transition of processes from lab scale to large manufacturing scale• Acting as a liaison to the manufacturing department during pilot and validation batches for APIs