Thomas Rollo Email and Phone Number

• Maintains lab instruments which may include but not limit to Mass Spec, HPLC, GC, and automation equipment, etc.• Performs the automation of assays utilizing the Hamilton robot.• Assesses the feasibility and troubleshoots the automation of assays.• Provides daily operation/method troubleshooting and instrumentation support.• Validates new instruments for operational use in the laboratories.• Writes and revises SOP's and other documents as appropriate.• Participates in monitoring and evaluating new instrumentation and technologies.• Assists team members in software validation lab testing related duties.• Validates and performs change control testing including the design/completion of tests to the software, and documenting results/installations as required by GLPs and/or SOPs.• Trains users in computer systems applications and data analysis/conversion techniques.• Collects, sorts, and assembles data/information from established and non-established sources.• Works with Information Technology to troubleshoot computer systems used in Metabolism.

Lab Skills -Provides complete and accurate records in accordance with the FDA,OSHA, EPA, DNR, DOT and other agencies guidelines in manufacturing of APIs-Routinely executes work with a high level of attention to detail, meticulousness and diligence. -Demonstrate solid time management and consistently meets deadlines set forth by management.SMO responsibilities-Identifies and corrects training issues, instruction problems, and new educational needs regarding specific equipment as a valuable resource for the manufacturing team.-Conducts inspections of lab spaces to ensure cleanliness and audit readiness. -Updates the quality system by revising OPs based on the equipment specifications. -Improves processes through application of scientific knowledge, experience and principles in compliance with change controls, CAPAs, and OPs.Technology and Communication-Overseas communication and documentation with different offices such as QA and QC regarding critical information on current production and schedules. -Proactively writes and revises OPS to identify safety and quality gaps.-Assists in initial training of new shift members and collaborates closely with the training department and supervisors to ensure readiness.-Maintains effective verbal and written communication using Trackwise, Veeva, SAP, and Microsoft Teams.

-Effectively managed concurrent oversight of 15+ pharmaceutical trials during drug dosing phases, demonstrating comprehensive understanding and management.-Specialized in preparing laboratory reagents, vehicles, diets, solutions/suspensions, syringes, and capsules in strict adherence to study protocols and SOPs for pharmaceutical development research in accordance with FDA regulations.-Developed ability to recognize deviations from normal results and promptly communicated issues to Study Directors, Principal Investigators, Formulations Coordinator, and management to uphold data integrity.-Committed to learning since summer internship in 2019, leading to certifications in Biosafety Level 2, Handling Highly Potent Material, and Aseptic Technique.