Andy Burcham Email & Phone Number

Golden Colorado

Perform preventative maintenance, repair and calibrate laboratory instrumentation to ensure availability of usage. Instrumentation includes High Performance Liquid Chromatographs (HPLC) and Gas Chromatographs (GC). Devise and validate methods for certified reference materials (CRM) and proficiency testing (PT) samples. Manufacture and verify certified reference materials (CRM) and proficiency testing (PT) samples.

Boulder, Co

• Responsible for conducting and writing formal production and lab investigation reports and exception reports.• Investigated for root cause of active pharmaceutical ingredient (API) deviations to determine impact to product stability, validation, quality, identity, potency, and purity.• Performed impact risk assessment, root cause determination, and appropriate corrective action and preventative action plans.

Broomfield

• Maintained laboratory instrumentation to ensure availability of usage. Instrumentation included uPLC, FT-IR Raman, LC, GC, Malvern and Horiba particle size analysis, DSC, TGA, dissolution baths and dissolution samplers.• Updated Standard Operating Procedures and managed change control for instrument updates and additions.• Managed vendor repair and preventative maintenance schedule. Kept instrument status up to date in the master list of equipment.

Broomfield, Co

•Technical Writer and manager of Annual Product Quality Review (APQR) System. Compiled data from Labware, Trackwise, and analyzed data for trending and metrics. • Communicated approved action limits to QC management for implementation into Labware. • Generated Quarterly reports for site management review and approval and also chaired the APR meeting with upper management. • Maintained approved Annual Product Review report database. • Supported Broomfield site during regulatory agency audits. Conducted internal audits in manufacturing. Conducted training for “inspection readiness.” Executed protocols at off-site packaging and shipping locations.

Broomfield, Co

• Developed and validated analytical chromatography methods for active pharmaceutical ingredients including but not limited to related compounds, dissolution, assay and residual solvents. • Transferred product methods from development to production laboratory and verified method precision/repeatability, specificity, peak purity, and linearity, stability of solution and USP comparison. • Developed, validated and implemented methods for automated dissolution workstation. • Routinely wrote protocols to define the scope of a project, deviations and investigations.

Broomfield, Co

• Worked in a team environment performing analytical testing and documentation for process validation, finished products and stability samples utilizing in-house and USP methods for assay, content, dissolution, related compounds, and identification.

Arvada, Co

• Analyzed organic samples for organo chlorine pesticides, PCBs, explosives, poly-nuclear aromatics and diesel range organics following EPA 600 and 8000 series protocols. • Maintained and operated HPLC and GC instrumentation. • Lead for organic prep group.

Boulder, Co

• Operated 1500 liter fermentation production of a recombinant hemoglobin product • Lysed cells using rotary drum vacuum filter and cuno filtration • Utilized aseptic technique following cGLP and cGMP protocols