Experience

Editas Medicine

• United States
• Biotechnology Research
• 100 - 200 Employee

• Senior QC Specialist, Method Validation

  • Oct 2021 - Present

  Cambridge, Massachusetts, United States

• Senior QC Analyst, Method Validation

  • Oct 2021 - Oct 2021

  Cambridge, Massachusetts, United States



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Associate Scientist

  • Mar 2011 - Oct 2014

  Longmont, CO •Responsibilities include providing clinical and commercial development support through product characterization, comparability, method development, method qualification and analytical testing. •Lead role in implementing a Global Whole Mass platform, streamlining whole mass analysis companywide increasing efficiency and reducing costs •Supporting regulatory filings by efficiently authoring protocols, generating analytical data, and authoring technical reports •Support product… Show more •Responsibilities include providing clinical and commercial development support through product characterization, comparability, method development, method qualification and analytical testing. •Lead role in implementing a Global Whole Mass platform, streamlining whole mass analysis companywide increasing efficiency and reducing costs •Supporting regulatory filings by efficiently authoring protocols, generating analytical data, and authoring technical reports •Support product characterization, elucidation of structure, and determination of forced degradation pathways. Author of several MA sections including forced degradation, and charge variant product characterization. •Supporting conformance and comparability testing for several molecules using analytical techniques such as peptide mapping, whole mass analysis, glycan mapping, RP, charge based and size based HPLC techniques. •Experience with several protein therapeutic platforms including monoclonal antibodies, peptibodies, and recombinant proteins. •Effectively communicate progress and potential hurdles to senior leadership team: very vocal, engaged, and professional contributor.

• Associate Scientist

  • Nov 1998 - Mar 2011

  Longmont, CO •Initiated a Technical Investment Project to develop a novel digestion procedure utilizing pressure cycling technology for peptide maps and deglycosylation. The project included a thorough comparison of pressure cycling, microwave, and conventional digestion procedures. •Initiated and implemented a program for coordinating and maintaining common laboratory supplies to increase efficiency for laboratory personnel and decrease costs •Developed and qualified a peptide map utilizing pressure… Show more •Initiated a Technical Investment Project to develop a novel digestion procedure utilizing pressure cycling technology for peptide maps and deglycosylation. The project included a thorough comparison of pressure cycling, microwave, and conventional digestion procedures. •Initiated and implemented a program for coordinating and maintaining common laboratory supplies to increase efficiency for laboratory personnel and decrease costs •Developed and qualified a peptide map utilizing pressure cycling technology and rapid resolution chromatography. This method also successfully combined non-reduced and reduced peptide maps alleviating the need to qualify two separate procedures. •Assessed the use of DCP technology to measure particle size distribution of samples associated with various steps in a peptibody process. •Safety representative for the Analytical Sciences Department for 2010. Duties included presenting monthly safety reports to the department, training staff in Job Hazard Assessments and Laboratory Safety •Performed routine assays using Amgen Methods such as Reversed Phase, SEC, CEX HPLC, IC, LC/MS peptide mapping, amino acid sequencing, and protein concentration using UV-vis spectrophotometry •Performed method transfers, method validations, and method training •Wrote, revised, and reviewed SOP’s, LP’s, and Analytical Methods •Support Process Development •Responsibilities included being System Owner of all Dionex IC systems, LC/MS systems and Beckman UV-vis •Performed analyses of raw materials, gas and water samples using Amgen and compendial methods, including TOC, LAL, pH, and conductivity •Responsibilities included writing SOP’s and methods, performing method transfers and ordering equipment and lab supplies.


Dartec
• United Kingdom
• Utilities
• Manager

  • 1992 - 1998