Danielle Johnston Email & Phone Number

New Brunswick, New Jersey, United States

New Brunswick, New Jersey, United States

Pennington, New Jersey

• Authored technical reports, including methods, validation plans and reports, method assessments and method development reports.
• SME for Impurity testing (CHO HCP, rProtein A ELISA, Insulin ELISA, DNA (qPCR) and beta glucan) with CROs and as a Single Point of Contact (SPOC) to provide scientifically sound advice to analytical team leads.
• Engaged manager of a small method development team.
• Developed robust in house, cell line specific or product specific ELISA methods for the… Show more
• Developed robust in house, cell line specific or product specific ELISA methods for the quantification of CHO HCP.
• Authored platform methods and method assessments for in-process impurities to align to best practices and meet accelerated timelines

Hopewell, NJ

• Authored technical reports, including methods, validation plans and reports, method assessments and method development reports.
• SME for Impurity testing (CHO HCP, rProtein A ELISA, Insulin ELISA, DNA (qPCR) and beta glucan) with CROs and as a Single Point of Contact (SPOC) to provide scientifically sound advice to analytical team leads.
• Engaged manager of a small method development team.
• Developed robust in house, cell line specific or product specific ELISA methods for the… Show more
• Developed robust in house, cell line specific or product specific ELISA methods for the quantification of CHO HCP.
• Authored platform methods and method assessments for in-process impurities to align to best practices and meet accelerated timelines

Hopewell, NJ

• Authored technical reports, including methods, phase appropriate validation plans and reports, commercial validation plans and reports and method development reports.
• Developed in house, cell line or product specific ELISA methods for the quantification of CHO HCP.
• Perform impurity testing using ELISA (CHO-HCP, rProA, Insulin) and Yeast-Glucan in cGMP environment
• Analyst in Phase-Appropriate Validation protocols and routine testing of GMP and non-GMP samples for presence of… Show more
• Analyst in Phase-Appropriate Validation protocols and routine testing of GMP and non-GMP samples for presence of impurities within the sample testing timeline.
• Liaise as a SME for Impurity testing (rProtein A ELISA, Insulin ELISA, DNA (qPCR) and Beta-Glucan) with CROs.

Hopewell, NJ

• Familiar with and work in cGMP environment
• Perform impurity testing using ELISA (CHO-HCP, ProA, Insulin, B12, Yeast Glucan, Binding ELISA) and AlphaLISA assays
• Developed and troubleshooting ELISA/AlphaLISA methods. Authored/co-authored resulting method; assist the automation and comparisons of assays
• Perform HPLC/UPLC using Empower-2 to perform affinity (ProA), size exclusion (SEC) and reverse phase chromatography for amino acid analysis (AAA).
• Participated in method… Show more
• Participated in method development for AAA

Bethesda, MD

• Developed protein expression vectors in bacterial and yeast systems; developed protein purification protocols for native and tagged proteins using various chromatographic methods including ionic, hydrophobic exchange.
• Performed native and non-native gel electrophoresis and Western blotting
• Tested protein folding using circular dichroism (CD), protease profiling and refolding… Show more
• Tested protein folding using circular dichroism (CD), protease profiling and refolding assays
• Developed in vitro amyloid formation and detection assays
• Developed, performed troubleshooting and trained individuals on fluorescence and absorbance based assays to monitor the formation of protein aggregates and amyloid fibrils, disaggregation/disassembly of aggregates and.

Phd, Biology

Bs, Biochemistry