Nick Gilbreath

Quality Focused Professional Chemist with experience in Laboratory, Compliance and GMP settings wanting to utilize my expertise to lead teams by promoting growth, development and collaboration. Excel at achieving balance in meeting critical quality-driven deadlines to comply with federal standards while maintaining high internal customer satisfaction levels. Consistently achieve exceptional results by streamlining processes, minimizing errors, and contributing to production of quality products.

Worked in a GMP setting for 16+ years.

Senior Quality Control Analyst, Aspex Chemistry at ALCON (2024-03 – Present)

• Investigator responsible for communicating and collaborating with third party organizations for Laboratory Escalations
• Leading and organizing analyst's workload to ensure timely closure of investigations and sample management
• Coordinate cross-functional teams for investigation resolution
• Review and release of finished products and stability
• Other Senior Quality Analyst duties as needed, see below.

Principal Analyst, ESO Compliance at ALCON (2022-01 – 2023-12)

• Integrated Eysuvis and Inveltys Products and CMOs into Alcon ESO Organization
• QA contact for CMO production, investigations, complaints, change control and audits.
• Perform Technical Batch Release and Approval to Ship for multiple Raw Materials, Intermediates and Products
• Coordinate PO issuance as well as Finished Product and Stability delivery, testing and report generation with multiple Contract Laboratories
• Coordinate with Global Regulatory Affairs for product requests and submissions

Senior Quality Control Analyst at ALCON (2017-01 – 2022-12)

• Lead investigator responsible for communicating and collaborating with third party organizations for Laboratory Escalations
• Leading and organizing analyst's workload to ensure timely closure of investigations and sample management
• Review of laboratory methods against current compliance and regulatory standards
• Draft and provide lab assistance and guidance for Product and Process Change Control
• Coordinate cross-functional teams for investigation resolution
• Review and release of finished products and stability
• Reporting of Quality Metrics for QC Chemistry
• Data Integrity Subject Matter Expert for Laboratory personnel at the site
• Writing, reviewing and training others for investigational summaries and laboratory procedures and documentation
• Audit Team Support
• Project Management experience with lab improvement projects
• Method and instrumentation validation and qualification experience
• Standards Coordinator: Order, manage and inventory standards for the Chemistry Laboratory. Collaborate with Alcon and Novartis Standard Suppliers to order and manage standards to meet business continuity needs.
• Training of coworkers, analysts and contractors in instrument operation, calibration, maintenance and troubleshooting
• Test finished pharmaceutical and OTC products for in-process, complaint, release and stability testing. Utilize both instrumentation and wet chemistry techniques to test to manufacturing release specifications

R&D Chemist at ZS PHARMA (2016-01 – 2017-12)

• Worked individually and with the R&D team on investigations and investigation reports
• Testing of Research and Investigational samples via X-Ray Diffraction and Scanning Electron Microscopy
• Experience with FDA Audits as an R&D analyst
• Developed procedures for instrument use, data integrity/traceability and performance verifications
• Writing and review of documentation
• Process Development - Process improvements
• Scale Batches
• Cleaning Processes
• Established R&D sample submission, receipt, and chain of custody programs

Quality Assurance Analyst II – Component Chemistry at ALCON (2010-01 – 2016-12)

• Managed release timelines for chemicals and components - Expected turnaround time of two weeks for routine testing
• Expedited release in 1-3 days to support manufacturing demand.
• Review of daily and investigational samples.
• Writing and reviewing of documentation.
• Tested raw materials & packaging components utilizing both instrumentation and wet chemistry techniques to manufacturing release specifications including USP, EP, JP, and NOC specifications.
• Trained analysts and contractors in instrument operation and troubleshooting
• In charge of lab waste disposal, responsibilities include preparing wastes to be Lab-Packed, training coworkers in proper disposal techniques and disposing of aqueous wastes.

Bachelor of Science in Chemistry with Minor in Biology – UNIVERSITY OF NORTH TEXAS (2009)