Experience

Invivoscribe

• United States
• Biotechnology Research
• 100 - 200 Employee

• Production Associate III

  • Jan 2014 - Present



Eurogentec

• Belgium
• Biotechnology Research
• 200 - 300 Employee

• Quality Control Associate

  • Sep 2011 - Dec 2013

  Performed all activities compliant with ISO 9001, ISO 13485 standards and cGMP regulationsAnalyze oligonucleotides for identity by mass via MALDI and for purity via ion-exchange and reverse-phase HPLC Interpret mass spectrometry and chromatography resultsRecord accurately all QC data for in vitro diagnostic (IVD) samples in batch recordsPerform batch release for IVD orders and release final Certificate of AnalysisTrain QC analysts on testing methods and perform peer review of QC dataWrite and revise cGMP compliant documents to support production activitiesResponsible for ensuring that all equipment in the QC laboratory is calibrated and maintainedInvestigate customer complaints and review process deviationsApprove incoming raw material Show less

• IVD Production Associate

  • Oct 2009 - Sep 2011

  Responsible for batch record documentation during production and for archiving completed records Purified oligonucleotides on reverse-phase and ion exchange HPLC and Elchrom gel electrophoresis Performed UV quantitation of in-process and final productsPrepared final samples for customer and created certificate of analysis for final productsCoordinated shipment of final product with the shipping department to include the packaging of and documentation for controlled temperature conditionsManaged stock of consumable materials used in the IVD cGMP clean rooms Responsible for ensuring that all equipment in the clean rooms was calibrated and working appropriatelyAssembled master mixesPerformed internal audits of other departments Show less



Pharmatek

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Pharmaceutical Chemist

  • Sep 2008 - Jul 2009

  Conducted preformulation studies to support final product solid dosage formulation efforts Managed stability studies to test drug substance and drug product stability requirements Developed solid dosage capsule formulations to enhance bioavailability Developed of a discriminating dissolution method for comparing capsule formulations Experienced in performing and optimizing reverse-phase and ion exchange HPLC methods Formulated aqueous drug suspensions for toxicology studies and confirmed homogeneity and chemical stability of formulations Author of protocols, test methods, and technical reports Participated in meetings, conference calls, and other interactions with clients Show less



Beckman Coulter Diagnostics

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Developmental Chemist Intern

  • Jun 2008 - Aug 2008

  Supported the automation of an existing process Conducted tests to verify limits on an existing assay by preparing and comparing historical, in-process, and new method data Optimized limit specifications and parameters on the newly developed automated system Supported the automation of an existing process Conducted tests to verify limits on an existing assay by preparing and comparing historical, in-process, and new method data Optimized limit specifications and parameters on the newly developed automated system



Edwards Lifesciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Research Intern

  • Mar 2007 - Oct 2007

  Developed chemical assays to support FDA approval for novel medical devices Successfully presented crucial research data to research group Communicated research findings via elaborate lab reports, presentations, and regular updates to managers Discussed potential alternatives to methods used Developed chemical assays to support FDA approval for novel medical devices Successfully presented crucial research data to research group Communicated research findings via elaborate lab reports, presentations, and regular updates to managers Discussed potential alternatives to methods used