Yasir Butt has over 20 years of experience in project management, quality assurance, and analytical testing. He is currently a project manager at Tandem Labs where he oversees projects outsourced from pharmaceutical companies, managing the full project lifecycle. Previously he worked at Alcon Labs and Novartis as a study monitor managing outsourced research studies. Butt has a bachelor's degree in medical technology and is proficient in GLP, GCP, analytical testing techniques, and laboratory information management systems.
Challenges in Clinical Data Analysis with RIan Cook
R is a full-featured and mature environment for clinical data analysis. However, a common misperception exists that R cannot support the various regulatory requirements for clinical data analysis. This presentation provides an overview of proceedings at useR! conferences and elsewhere regarding the acceptability of use of R in regulated environments, e.g., clinical trials for pharmaceuticals and medical devices.
Challenges in Clinical Data Analysis with RIan Cook
R is a full-featured and mature environment for clinical data analysis. However, a common misperception exists that R cannot support the various regulatory requirements for clinical data analysis. This presentation provides an overview of proceedings at useR! conferences and elsewhere regarding the acceptability of use of R in regulated environments, e.g., clinical trials for pharmaceuticals and medical devices.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
A detail-oriented, sincere and hardworking individual with a Master of Science and Over Fourteen years of GLP/GMP work experience
Expert in Audit trails review in Empower, Lab solutions, Tiamo and other softwares.
Experience in theoretical and practical knowledge in calibration, preventive maintenance, troubleshooting and problem solving of critical equipment like HPLC, GC, Auto Titrator,DR and UV-Spectrophotometer etc.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
A detail-oriented, sincere and hardworking individual with a Master of Science and Over Fourteen years of GLP/GMP work experience
Expert in Audit trails review in Empower, Lab solutions, Tiamo and other softwares.
Experience in theoretical and practical knowledge in calibration, preventive maintenance, troubleshooting and problem solving of critical equipment like HPLC, GC, Auto Titrator,DR and UV-Spectrophotometer etc.
Bootstrapping or Investor Funding: Which is Best?Brian Bamberger
When it comes to starting a company that offers products and services to the pharmaceutical industry, funding can be a big issue. Is it better to bootstrap your new company or seek out investor funding? We evaluate the pros and cons of each type of funding in this slide deck. #pharmafunding
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
•DiSC and Customer Service (8 Contact Hours) Alabama Reference Labs, Montgomery Alabama.
•Business Writing (12 Contact Hours) Alcon Labs, Fort Worth Texas.
•How To Communicate with Professionalism (12 Contact Hours) Alcon Labs, Fort Worth Texas.
•Velquest Operator Training CFR 21 Part 11 Software Tandem Labs, Salt Lake City Utah.
•Managing Multiple Projects, Objectives and Deadlines (SkillPath) Tandem Labs, Salt Lake City Utah.
•Secrets and Development in GC and GC/MS (Agilent Technologies) Tandem Labs, Salt Lake City Utah.
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.