Randy Nielsen work email
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Randy Nielsen personal email
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Pharmaceutical CRO Developed and validated analytical methods to ICH guidelines. Managed product development and stability contracts for multiple clients. Managed budget and development team.Medical DiagnosticsDeveloped immunoassay prototypes into commercial products. Technical team leader and liaison to several departments. Provided technical support to Manufacturing (raw materials, instrumentation, install corporate database).GoalsContinue work in product development which utilizes my technical expertise and project management experience.Specialties: Analytical methods and formulation development, immunoassay development, project management, liaison to clients and other departments
Eurofins Advantar
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Project DirectorEurofins Advantar
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Project DirectorEurofins Us / Advantar Aug 2016 - PresentGreater San Diego AreaManage analytical method development, method validation, and stability studies for pharmaceutical customers.
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Sr. Development ScientistPrometheus Laboratories Inc., A Nestlé Health Science Company Apr 2013 - Aug 2016Greater San Diego AreaScientific manager of new product and process development. Improve performance of existing assays and deliver robust processes. -
Assistant Professor (Summer)Cal State San Marcos Jun 2012 - Aug 2016San Marcos, CaTaught Bioprocessing & Bioengineering, BIOT 620 graduate level course from industry perspective. Focused on pharmaceutical and medical device industries. Taught course 5 summer semesters. -
Sr. Process ScientistAccumetrics Mar 2011 - Apr 2013San DiegoCharacterize raw materials and final reagents. Introduce objective analytical test methods. Develop reference materials. Streamline manufacturing processes.
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Analytical Methods And Formulations Development ScientistAdvantar Labs Oct 2010 - Mar 2011Develop analytical methods and formulations for new drug products. Perform compatibility (in-use) studies to support toxicology and clinical studies. Project and laboratory management.
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Manager, Qc And StabilityCatalent Pharma Solutions Mar 2009 - Jun 2010Managed stability and development programs for several clientsAssigned laboratory tests to QC chemistsDesigned protocols and prepared reportsUsed Lean System for Managing (LSFM) to streamline project management and facilitate communicationManaged monthly budget forecastDocumented deviations and Out of Specifications in QA data baseInvestigated and resolved Out of Specification resultsTroubleshot failing assaysProvided weekly client updates -
Group Leader, Analytical And Formulation DevelopmentCatalent Pharma Solutions Oct 2004 - Feb 2009Transferred, developed and validated analytical methods (HPLC, GC, IC, and ELISA) to ICH GuidelinesPerformed TOC, KF, DSC and particle size characterizationResponsible for USP and EP compendial test methodsPerformed ICH light stress and stability studies Screened new drug product formulationsOptimized lyophilization formulation and run cyclePerformed "In-Use" studies to simulate product use in clinicDesigned protocols and prepared reportsManaged multiple product development contracts and clientsProvided weekly updates to clientsManaged research group
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Team Leader, QcCardinal Health Jul 2003 - Sep 2004Managed a group of 9 QC chemistsDocumented deviations and Out of Specification results in QC databaseInvestigated and resolved Out of Specification resultsProvided weekly client updates
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Senior Scientist, Analytical DevelopmentCardinal Health May 2002 - Jun 2003Transferred, developed, and validated analytical methodsScreened new drug product formulationsSimulated manufacturing steps (autoclave or processing)Prepared reports and test methodsProvided weekly updates to clients
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Development ScientistBeckman Coulter Apr 2001 - May 2002I was a member of Immunomics Operations.1. Transferred Tetramer preparation procedures from Research to Manufacturing. 2. Raised proteins using E. coli and Drosophila (insect) expression systems. 3. Optimized preparative immunoaffinity chromatography to purify expressed proteins. 4. Prepared fluorescence calibration system to monitor product stability. -
Product Development ScientistBeckman Coulter 1993 - Apr 2001Developed prototype immunoassays into commercial products. This typically included many activities: assay and component optimization, raw material selection, process scale-up, calibration assignment, preparation of calibrators and controls. As technical team leader, I was the liaison to raw material suppliers and several departments: Research, Manufacturing, Clinical and Regulatory, and Marketing.
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Research ScientistHybritech, Inc 1989 - 1993I was a member of Manufacturing Technical Support.1. Characterized raw materials for qualification, investigation and substitution. The techniques included HPLC, gel electrophoresis, ELISA, and NMR. This work also included supplier audit visits.2. Acquired equipment to support Manufacturing and raw material inspection.3. Managed installation, training and validation of corporate chromatography database.4. Revamped corporate calibration procedures for UV spectrophotometers.
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PostdocEli Lilly And Company Aug 1987 - Sep 1989Capillary Electrophoresis of Recombinant Proteins1. Used well characterized human recombinant proteins (insulin and growth hormone) and their derivatives to study the separation power of capillary electrophoresis.2. Characterized instrument prototypes for various manufacturers3. Rigorously compared RP-HPLC and CE separations for protein digests to demonstrate the orthogonal nature of these techniques.4. Separated antibody antigen complexes from noncomplexed species in CE.
Randy Nielsen Skills
Randy Nielsen Education Details
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Chemistry -
Chemistry
Frequently Asked Questions about Randy Nielsen
What company does Randy Nielsen work for?
Randy Nielsen works for Eurofins Advantar
What is Randy Nielsen's role at the current company?
Randy Nielsen's current role is Project Director at Eurofins Advantar.
What is Randy Nielsen's email address?
Randy Nielsen's email address is rn****@****abs.com
What schools did Randy Nielsen attend?
Randy Nielsen attended University Of Arizona, California State University-Fresno.
What skills is Randy Nielsen known for?
Randy Nielsen has skills like Immunoassays, Gmp, Glp, Chromatography, Project Management, Hplc, Analytical Chemistry, Elisa, Protein Chemistry, Pharmaceutical Industry, Gas Chromatography, Validation.
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