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MICHAEL D. SANFORD
Senior Analytical Chemist
New Orleans,LA
Summary
Result-driven Analytical Chemist with twenty-two years’ experience in QA/QC analytical method testing to support production, process streamlining & optimization, regulatory compliance testing and documentation, and production technical support. Twenty years of highly successful manufacturing technical support raw material testing, in - process testing, and finished goods release testing/certification for GLP, GMP, cGMP, USP/FDA, ICH, and ISO17025 analytical methods compliance documentation, process auditing, testing method validation/qualification, data review verification, standard testing methods execution, lab safety, and instruments/methods training. Fifteen years of comprehensive training and experience in LIMS, SRP, QMS software systems, data automation, and database management. Insightful Senior Analytical Chemist recognized for high productivity and efficiency in completing tasks. Specialize in chromatography, spectroscopy, and mass spectrometry, ensuring precise analytical results. Excel in critical thinking, problem-solving, and teamwork to drive successful project outcomes. Committed to maintaining high-quality standards and continuous improvement in all laboratory processes.
Overview
29
29
years of professional experience
Work History
Senior QC Chemist
A.N.I. Pharmaceutical
Baudette
10.2022 - 04.2024
- Executed quantitative confirmation analysis for in-process and finished product tablets, capsules, and solutions for USP testing using GC(FID, TCD), HPLC, Karl Fisher auto-titration, FTIR, UV/VIS; conducted dissolutions, blend/content uniformity, and USP limit tests; maintained laboratory instruments; oversaw lab housekeeping; executed QDF peer-review; generated customized Empower reports; managed instrument qualification documentation.
- Conducted routine quality control tests on pharmaceutical products.
- Analyzed chemical compositions using advanced lab equipment and techniques.
- Reviewed and documented testing results for compliance with industry standards.
QC Supervisor/Lab Supervisor
KIK Custom Product
Elkhart
02.2017 - 06.2018
- Oversaw daily operations of QC testing lab, including raw material receipt, in-process samples, process validation, stability samples, and finished product testing, ensuring compliance with ISO 13485, ISO 17025, and 21 CFR Part 11, 210, 211, and 820.
- Executed QC investigations, OOS reports, and CAPA resolutions, while enhancing lab testing processes through validation, method transfer, and continuous improvement initiatives.
- Supervised quality control processes to ensure product compliance with standards.
- Trained staff on quality inspection techniques and safety procedures.
- Conducted regular audits of production lines for adherence to quality protocols.
Senior Analytical Chemist/Material Testing Engineer II
Collabera @ Honeywell
South Bend
02.2013 - 02.2015
- Performed anodize line SPC testing, conducted wash tanks QA/QC testing, executed QA/QC material testing, completed qualitative QA XRF inspection, analyzed failures/FOD using FTIR and micro-Raman, and carried out micro-dispersive Raman analysis of carbon fiber.
- Created technical documentation, prepared anodize solutions for production, executed SAE limit testing, performed fuel testing, analyzed wear, TAN, viscosity, and particles, managed laboratory inventory, offered LIMS technical support, reviewed SEM data, conducted ISE analysis, performed wet chemistry testing, and executed micro-FTIR analysis.
- Conducted complex analyses using chromatography and spectroscopy techniques.
- Developed and validated analytical methods for various chemical compounds.
- Collaborated with cross-functional teams to support product development initiatives.
Analytical Chemist
BreakThroughIt @ Pfizer Global Manufacture Production
Kalamazoo
08.2011 - 04.2012
- Led development and validation of cleaning validation methods for new products, enhancing product safety and quality assurance processes.
- Developed and optimized cleaning validation methods for APIs, step reaction components, and residual solvents, ensuring compliance with regulatory standards.
- Evaluated compounds for super method, validating linearity, accuracy, and swab surface recoveries to ensure reliable analytical results.
Analytical Chemist
Kelly Scientific Resources @ ADM Glycols Division
Decatur
10.2009 - 10.2010
- Conducted quantitative confirmation analysis and raw material and in-process testing for USP/NF glycerin and propylene glycol derived from crude bio-fuel waste stream using analytical techniques including GC (FID, TCD), HPLC, ICP, ion chromatography, densitometer, refractive index, Karl Fischer auto-titration, FTIR, UV/VIS, and ISE/pH analysis to ensure product quality and regulatory compliance.
- Executed USP/NF limit tests, maintained laboratory instruments for optimal performance, developed and validated QA/QC SOPs, and ensured compliance with GMP and USP standards to uphold product integrity.
- Conducted chemical analyses using chromatography and spectroscopy techniques.
- Developed and validated analytical methods for product testing.
- Maintained laboratory equipment to ensure optimal performance and compliance.
Analytical Chemist
Volt Services Group @ Eli Lilly
Indianapolis
05.2007 - 12.2008
- Performed quantitative and qualitative GLP analysis supporting small organic molecule development for pharmaceuticals across phases, including scale-up optimization, process analytical control strategy, in-process and final product manufacturing campaigns, synthetic route mechanism, solvent isolation, and commercial route optimization.
- Conducted dissolution, API stability, packaging stability, and raw material acceptance studies; executed Capillary Electrophoresis analysis; developed analytical methods for production clean-out.
- Conducted analysis of raw materials and finished products for quality assurance.
- Utilized chromatography and spectroscopy techniques for compound identification.
- Maintained laboratory equipment to ensure optimal performance and accuracy.
Senior Analytical Chemist
American Institute of Toxicology
Indianapolis
06.2005 - 03.2007
- Conducted quantitative confirmation analysis on 180 pharmaceutical drugs and metabolites across six matrices (urine, blood, organs/tissue, vitreous, saliva, feces) to ensure compliance with regulatory standards.
- Utilized GC (FID/NPD), GCMS, HPLC, LCMS, and LCMSMS for confirmation methods, enhancing reliability of analytical results.
- Conducted chemical analyses to identify toxic substances in various samples.
- Developed and validated analytical methods for testing environmental pollutants.
- Collaborated with multidisciplinary teams to ensure regulatory compliance in studies.
Chief Chemist
Deloro Stellite Coatings, Inc
Goshen
07.1995 - 08.2004
- Coordinated lab training, validated testing methods, qualified instruments, and authored technical documents to ensure compliance with ASTM, GLP, ISO17025, ISO/QS2000, NADCAP7200/1, and GMP standards.
- Conducted visual inspections and particle analysis, and supported R&D with weld inspection and metallurgical sample preparation.
- Led research projects on advanced coating materials and applications.
- Developed and refined chemical formulations for improved product performance.
- Oversaw quality control processes to ensure compliance with industry standards.
Education
Organic Department specializing in organometallic synthesis and analytical instrumentation characterization and method development
Purdue University
West Lafayette, IN07-1993
B.S. - Chemistry A.C.S. certified with a minor in Math
Xavier University of Louisiana
New Orleans, LA12-1991
Chemistry A.C.S. certified with Physics minor & Naval Science R.O.T.C. minor Tulane University
Loyola University of New Orleans
New Orleans, LA05-1991
Skills
- QC compliance testing
- Lab QMS testing standards
- Production technical support
- Quantitative/Qualitative analysis
- GC-MS
- LC-MS
- HPLC/UHPLC
- Multi-Nuclei NMR Spectroscopy
- Atomic Absorption
- Spectroscopy: UV/Vis, FTIR, XRF, XRD, & micro Raman/FTIR
- ICP/OES
- ICP/ICP/MS
- Lab instruments purchase/specification
- Analytical Methods Qualification
- IO/OQ/PQ documentation/specification
- Lab Instrument Metrology
- LIMS/SDMS/Instrument Data automation
- Lab Reports generation using Crystal Reports, X-Y Control Charts, Xbar-R Charts, & SPC
- Quality Management: SAP, CPAT, 6-Sigma, 5S, SPC, ISO 17025, ISO 9001:2010, NDCAP, CLSI, & 40 CFR Parts 792, 172, 160, & 160:EPA
- Lab Productivity
- Ion Chromatography
- Chromatography Data Systems: Empower, Chemstation, Chromeleon, TotalChrom, EZChrom, & OpenLab
- Mass Spec software: Xcalibur, Analyst, Mass Hunter, Mass Lynx, TurboMass, &
- Differential Scanning Calorimetry
- Thermal Analyzers: DSC, TMA, TGA, &
- Automated Qualitative analysis
- Automated Quantitative analysis
- Immunoassay Analysis
- Capillary Electrophoresis
- Physical properties testing: Viscosity, Turbidity, pH/ISE, Rheology, Density/SG, Refractive Index, Moisture (Oven KF, KF, Drying), Cyclic Voltammetry, Boiler water analysis, visual inspection, microscopy, & visual analysis
- Automated testers: Tensile, Adhesion, Hardness, micro Hardness, & Surface friction
- LIMS: System administration, Data entry, records auditing, LIMS design specification
- LIMS: StarLims, WinLims, Nautilus, SQL Lims, LabVantage, LabWare, & SampleManager
- NuGenesis Scientific Data Management System
- EHS Workplace safety/Lab safety audits
- Lab inventory management/Chemical Disposal
- MSDS compliance
- Technical writing: Resolution of OOT, OOS, LIRs, NCs, RCA, CAPA, methods, working Instructions, & QMS documents
- Lab Proficiency testing/Staff evaluation
- Lab Staff: training documentation, mentoring, conflict resolution
Accomplishments
- Deans List 1990
- Monsanto Research Grant, 1990-1991
- Phi Lambda Upsilon (Chemistry Honor Fraternity)
- G.E.M. Fellowship
Timeline
Senior QC Chemist
A.N.I. Pharmaceutical
10.2022 - 04.2024
QC Supervisor/Lab Supervisor
KIK Custom Product
02.2017 - 06.2018
Senior Analytical Chemist/Material Testing Engineer II
Collabera @ Honeywell
02.2013 - 02.2015
Analytical Chemist
BreakThroughIt @ Pfizer Global Manufacture Production
08.2011 - 04.2012
Analytical Chemist
Kelly Scientific Resources @ ADM Glycols Division
10.2009 - 10.2010
Analytical Chemist
Volt Services Group @ Eli Lilly
05.2007 - 12.2008
Senior Analytical Chemist
American Institute of Toxicology
06.2005 - 03.2007
Chief Chemist
Deloro Stellite Coatings, Inc
07.1995 - 08.2004
Organic Department specializing in organometallic synthesis and analytical instrumentation characterization and method development
Purdue University
B.S. - Chemistry A.C.S. certified with a minor in Math
Xavier University of Louisiana
Chemistry A.C.S. certified with Physics minor & Naval Science R.O.T.C. minor Tulane University
Loyola University of New Orleans