Alcon Laboratories IncJanuary 2011 to January 2015Senior QA Analyst I Fort Worth, Texas
Manage and Perform Analytical Method Transfers with Alcon R&D, Sandoz R&D, Alcon Manufacturing Plants in Puurs, Singapore, Brazil, and Barcelona while ensuring the method validations meet ICH Guidelines and Novartis Quality Manual requirements; this includes authoring AMT Protocols, Reports, and Procedures as well as performing the analysis and ensuring that other analysts are trained to perform the new procedures.
Projects such as Residual Solvent Certifications; Intensive GC analysis of residual solvents for all part numbers including verification of validation and reports to certify testing meets regulatory guidelines.
CPAT Validation Remediation; determine gaps in validations, how to meet ICH guidelines, author protocols for validation work, and author reports.
Investigate method issues such as UV Correction Factor for Brimonidine.
By planning an effective protocol to correctly determine the Correction Factor, allowed Alcon to keep manufacturing SimBrinza.
Plan and perform investigations such as Ethylene Glycol in Pluronic; established that ethylene glycol is not present in Pluronic so that manufacturing could resume with current inventory.
Perform Method Verifications to Alcon and Novartis standards in Global Compendia; Europe, Japan, India, China and United States at a cost savings of $100,000 anually.
Train analysts on HPLC and GC methods; ensuring that quality is consistent throughout the team.
Train analysts to perform method validations, method verifications, and instrument qualifications.
Proficient in IT Applications; CATSWeb, Chromeleon, Empower, ARMS, LIMS.
R & D, Analytical Chemistry, Scientist (Contracted through Manpower Professional), 20002011 Developed, Validated, and Authored Technical Procedures for Preservatives which were used in the successful FDA submission of a Drug Product.
These methods were transferred to ASPEX QA for manufacturing of the Product.
Investigated Derivitization Agents for an important Drug Product assay so that manufacturing was not interrupted.
Conducted Special Study to solve low assay results of a preservative for a product important to company's market share.
Demonstrated ability to learn new technology quickly and effectively, producing quality results for clinical supplies and toxological studies.
Troubleshooting multiple technical procedures to vastly improve results and testing efficiency.
Planned and Conducted method development/validations for products and raw materials.
Experienced with creating global test methods for multiple jurisdictions.
Polymer characterization, validation of tests and specifications.
Extensive experience with Alcon Products, Analytical Instrumentation and Software.
Performed Analytical Method Transfers; to Puurs, Cedarburg, Covance, and Aspex Product and Device Experience: Tobradex, Tobradex AF, Cilodex, Nepafenac, Systane, Moxidex, Vigamox, DuoTrav, Azopt, Patanol, Travatan, BSS Plus, AcrySof, AcrySof II, Provisc, Cellugel, Lubrilast, PMMA, Acrysert Drug Substance and Raw Material Experience: Tandospirone, AL-39324, Anecortave Acetate, Latanoprost, Tobramycin, RTKi, Sodium Hyaluronate, Levobetaxolol, Fluorescein, Olopatadine, HETE, Ciprofloxacin, Nebramine, Tyloxapol, Brinzolamide, Triamcinolone, PEG, Timolol, Leachates, Perkadox 16, Monomers, oMTP, PEA, PEMA, HEMA, BDDA, Inhibitors, Resins, Blue Blocker, Next Generation IOL Materials Independent Studies: free phenol, peroxides, aldehydes, 2,4 DNFB derivatization, Polyquad uptake Proficient in Chromatographic Techniques; UPLC, HPLC, GC, TLC and other Modes of Analysis; TGA, FT-IR, Autoanalyzer, Autotitrator, UV-VIS, Viscometers, pH, Osmolality, Nepholos, and Solid Phase Extraction (Empower, Chromeleon, Skalar, LIMS).
Alcon Laboratories IncJanuary 1990 to January 1992R & D, Intraocular Lenses, Biomaterials Research, Scientist I Fort Worth, Texas
Active team member in the Successful development of the MASL material to the AcrySof IOL by solving the tack problem with plasma surface treatment which was patented.
Developed a biocompatible surface modification for PMMA Intraocular Lenses using C-18 plasma.
Transferred method from University of Washington biomaterials research group to Fort Worth.
Alcon Laboratories Inc Ophthalmology GroupJanuary 1988 to January 1990Associate Scientist Fort Worth, Texas
Chemical and physical analyses of R&D Raw Materials including Method Development, Validation, Stability, Experimental Raw Materials, and Analytical Reference Standards.
Special Projects such as presenting Betaxolol Raw Material Stability TLC results for Japan filing.
Atlantic Research CorpJanuary 1984 to January 1988Scientist Supervisor and Analyst Camden, AR
in chemistry laboratory for production of solid rocket motors for the Army and Navy.
Experienced with handling explosives.
Education and Training
University of North TexasMaster of Science: ChemistryDenton, TexasChemistry
Harding UniversityBachelor of Science: ChemistrySearcy, ArkansasChemistry