Phil Callahan

Thornton, CO ***** www.linkedin.com/in/philcallahan

Systems Analyst / Data Scientist

Experienced, innovative Systems Analyst/Data Scientist with extensive pharmaceutical and quality background. Proven track record reducing operating expenses and bringing visibility to key performance indicators through data trending. Possess excellent communication, leadership, analytical and problem-solving skills with a strong focus on customer and employee satisfaction.

• Master’s in Data Science (2022, GPA 4.0)

• Lab Information Management Systems

(LIMS) Admin

• Chromatography Data Systems (CDS)

Admin

• Business Intelligence Admin

• Document Management Lead

for Pharmaceutical Regulatory

Inspection Prep Room (over ten

inspections)

Technical Summary

* Strongest expertise

Languages C++, Hive, HTML, Java, MDX, PHP, Pig, Python*, R*, Scala, Spark, SQL*

Software AWS, ChemStation, Empower CDS, Epic, Labware LIMS, MS Excel*, MS Word, SharePoint, Tableau

Phil Callahan

Thornton, CO 80233 • www.linkedin.com/in/philcallahan Professional Experience

Novartis, Denver, Colorado

Novartis is a Swiss multinational pharmaceutical company. It is one of the largest pharmaceutical companies by both market cap and sales. Business Systems Analyst 2015 - 2020

Provided support for Quality Control Lab chromatography instrumentation, LIMS builds, harvested site QC metrics, and drove process efficiency through business intelligence.

• Validated first MS Excel spreadsheet in Sandoz North America for GMP use which eliminated five to ten hours of hand calculations and clerical errors per week for that product.

• Designed internal SharePoint webpage and metric to track Lab Service Department’s in- service instruments trend and communicate real-time up to site and global leadership.

• Facilitated first zero-finding FDA inspection to site in thirteen years as Doc Management Lead in Prep Room and Scribe on QC Lab Tour.

• Partnered with team to convert Microbiology Lab’s Environmental Monitoring program from non-compliant Access database to CFR Part 11 compliant LIMS module. Microbiologist 2011 - 2015

Maintained controlled specifications according to USP and NF for Environmental Monitoring of processing rooms, raw materials, and water. Tested incoming media and outgoing product. Biochemically identified failures.

• Designed and implemented Kanban system for storage and replenishment of internal media which allowed for reduction of headcount due to efficiency gain.

• Improved site compliance by creating microbial risk assessments using failure modes and effects analysis for USP <1115> and Environmental Monitoring.

• Avoided regulatory finding by partnering with Lab Systems to migrate Stability results from outdated non-compliant platform (ScienTek) to CFR Part 11 compliant LIMS

(LabWare).

Production Facilitator 2011

Drove closure of CAPAs, Deviations, and SOP revisions by adhering to aggressive deadlines and collaboration with numerous teams and shifts. Created and presented much of site’s training material.

• Improved several of the most problematic SOPs responsible for human error Deviations by creating diagrams, organizing workflow, and Info Mapping. This effort dropped the SOPs out of top thirty for error-prone procedures. Phil Callahan

Thornton, CO 80233 • www.linkedin.com/in/philcallahan

• Implemented complete re-design of gowning process by re-writing the manufacturing gowning SOPs, training entire site, pricing and sourcing new gowning materials, and developing visual aids like posters.

• Maintained site compliance by creating and training entire site on four FDA-mandated monthly cGMP courses.

Tableting Technician 2009

Operated and maintained tableting press on shop floor. Responsible for all aspects of tableting run including cleaning, assembling, setup, and tear down. Older Experience, Wisconsin

Chem Lab Manager, Hutchinson Technology, 2005 – 2008 Responsible for maintaining chemistry of proprietary machinery involved in the hard drive suspension making process (Developers, Etchers, Strippers, Gold/Nickel Plating Lines, Clean Lines, etc.)

Managed 4 - 6 direct reports (L&A, corrective action, etc.) GC, Auto-titrator, AA, CVS, ICP, UV-Vis, Anton Paar spec. grav., pH, conductivity, HAZWOPER certification, Scanning Electron Microscopy (SEM) - Hard Particle Analysis, GLP, ISO, PM's (preventative maint.), LIMS, Lotus Notes

Quality Control Chemist, Hydrite Chemical Co., 2005 Responsible for testing, approving, and recording samples to be shipped/received and recorded. Gas Chromatography (including maintenance/troubleshooting), Karl-Fischer Titrations, GLP, proofing alcohol (according to ATF standards), Spectrophotometry, Refractometry / BRIX, Hydrometry / specific gravity Education

2022, MS, Data Science, University of Wisconsin

2003, BS, Biology, University of Wisconsin - Eau Claire, Eau Claire, WI Publications

Mobile Image Ratiometry: A New Method for Instantaneous Analysis of Rapid Test Strips; Nature Precedings : doi:10.1038/npre.2012.6827

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