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- 1. MR YASIR BUTT 5060 S Ellerby Ct, Salt Lake City, Utah 84117 | H: (801) 815-0170 | C: (801) 815-0170 | retaane@gmail.com Professional Summary Experienced professional with excellent client and project management skills. Action-oriented with strong ability to communicate effectively with technology, executive, and business audiences. Strong web based sales skills. Core Qualifications Operations management. Change management. Training and development. Reports generation and analysis. Multi-Task Management. Client Relations. Online Sales. Public Speaking Multilingual. Power-point Presentations. Customer Engagement. Customer Engagement. Familiarity with Agile Project Management. GLP/GCP Phase 1-3 Bioanalysis. CFR 21 part 11 and 58. HPLC/MS/MS and GC/MS/MS operations. Quality Assurance. Quality Control/CAPA. GLP Site/Study Directed Audits. CRO GLP/GCP Monitoring. EMEA, FDA, MHLW GLP Regulations. Corrective And Preventative Actions (CAPAs). Regulatory Pharmacovigilance. Experience (2000-2013) Project Management Team 12/2013 to Current Tandem Labs Salt Lake City, Utah Project Management/Study outsourced Project Management on Projects Outsourced to organization from international Pharmaceutical companies developing drugs for multiple therapies (TK and PK). Responsibility for full project cycle from quote submission, financial grant initiation, sample shipment arrangement/notification, validation, sample analysis, QC'd/QA'd data critique, CAPAs, report review and approval/finalization. Study Monitor (Project Manager Outsourced Research Studies) 04/2010 to 10/2012 Alcon Labs/Novartis Salt Lake City, Texas Project Management/Study outsourced Project Management on Projects Outsourced to CROs (TK and PK) including full project cycle quote submission, financial grant initiation, sample shipment arrangement/notification, validation, sample analysis, QC'd/QA'd data critique, report review and approval/finalization. Prepared weekly update to update stakeholders on project status and completion. GLP/GCP Protocols, GLP/GCP Study Monitoring. Oversaw data technical laboratory reports, analytical methods from CROs conducting outsourced studies. Communicated with Project Managers in CROs to represent Alcon and provide study over sight. Participated in contract lab conference calls for project delivery dates oversight and updates as well as troubleshooting. Assisted in directed study/Facilities QA audits of CROs for contract and GLP/GCP regulation compliance. Addressed QA findings and review/input to QA observations, and CAPAs. CRO Technical Staff Trainer GLP/GCP Phase 1 10/2002 to 08/2008 Tandem Labs Salt Lake City, Utah Responsible for assessing and developing standardized Laboratory "Best Practices". Part of the Company Presidential Award 2003 "going above and beyond call of duty award" winning Team that generated over 1 million dollars in revenue in one month for the division. Trained New staff on GLP/GCP laboratory functions including wet lab techniques, GLP/GCP Phase 1, OSHA, Analyst and Watson LIMS use.
- 2. Trained new staff on electronic lab notebook (Velquest) functions. Served in cross functional team on CFR 21 part 11 software systems as a user and release tester for different modules. Utilized LC/MS/MS and GC/MS/MS testing for complex bio-analysis for all phases of GLP/Research Drug Development for International Pharmaceutical companies. Lead studies audited by FDA/Clients without 483 citations. Met with clients during audits to update and discuss technical aspects of current and forecasted Projects. Helped the Director in formulating/amending Standard Operating Procedures. Participated in contract lab conference calls for Project delivery dates and updates as well as troubleshooting. Proficient in MDS Sciex API 5000, 4000, 3000 MS/MS operations and data analysis. Research Scientist 12/2000 to 10/2002 Northwest Toxicology Salt Lake City, Utah Performed (complex analytical) tests to identify drugs of abuse in Urine and Tissue. Handled, forensic samples including blood, hair and oral fluids. Utilized complex testing GC/MS, Thin Layer Chromatography (Toxi-Lab), GC/FID techniques. Maintained and Troubleshot Instruments. Performed rigorous revisions of generated data, including Chain of Custody documentation, QA and QC data per (SAMHSA and CAP, FRA) regulations. Functioned in Senior Scientist Capacity in the department; duties included but not limited to: training new staff, revisions of Standard operating Procedures, research and method development. Worked alone, and with the manager of the department to implement new procedures, efficiency parameters and guidelines (to satisfy protocols). Education Bachelor of Science: Medical Technology University of South Alabama Mobile 1995 Mobile, Alabama, USA Professional Development •DiSCandCustomerService(8ContactHours)AlabamaReferenceLabs,MontgomeryAlabama. •BusinessWriting(12ContactHours)AlconLabs,FortWorthTexas. •HowToCommunicatewithProfessionalism(12ContactHours)AlconLabs,FortWorthTexas. •VelquestOperatorTrainingCFR21Part11SoftwareTandemLabs,SaltLakeCityUtah. •ManagingMultipleProjects,ObjectivesandDeadlines(SkillPath)TandemLabs,SaltLakeCityUtah. •SecretsandDevelopmentinGCandGC/MS(AgilentTechnologies)TandemLabs,SaltLakeCityUtah. Computer and Software Proficiency Pharma/Medical Device IT Platforms (CFR 21 Part 11) Watson Analyst. Velquest (SamrtLab). Health Care Patient Information LIMS. Antrim. Cerner. HL7 Operating Systems. Windows (95, 98, 2000, XP, Vista, 7 and 8). Apple IOS 5 and 6. Productivity. Microsoft Office Suite (Power Point emphasis) Adobe Acrobat 9 Pro. Intuit Quick Base.