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 • 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 quantification of CHO HCP.• Authored platform methods and method assessments for in-process impurities to align to best practices and meet accelerated timelines• Implemented SAS JMP analysis to statistically evaluate method performance, a “power user” for JMP applications within impurities group.• Review reporting and documentation in GMP notebooks, Symyx electronic notebook, LIMS system • Analytical Team Lead (ATL) for a project, represent molecular and analytical development as part of integrated development team (IDT)• Interact in a cross-functional environment to communicate method procedure and analysis among different departments; representative on matrix teams as to support business operations Show less

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 • 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 quantification of CHO HCP.• Authored platform methods and method assessments for in-process impurities to align to best practices and meet accelerated timelines• Implemented SAS JMP analysis to statistically evaluate method performance, a “power user” for JMP applications within impurities group.• Review reporting and documentation in GMP notebooks, Symyx electronic notebook, LIMS system • Analytical Team Lead (ATL) for a project, represent molecular and analytical development as part of integrated development team (IDT)• Interact in a cross-functional environment to communicate method procedure and analysis among different departments; representative on matrix teams as to support business operations Show less

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 • 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 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.• Provide scientifically sound advice to analytical ream leads as an SME.• Ensure accurate results entry, reporting and documentation in paper notebooks, Symyx electronic notebook, LIMS system (DevLIMS and PD-LIMS)• Interact with other departments to communicate method procedure and analysis among different departments• Trained and implemented using JMP software to statistically evaluate method performance. Show less

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 • 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 development for AAA • Perform A280, using cuvette and plate based UV-VIS Spectrophotometers; involved in the method development of SoloVPE• Perform dynamic light scattering (DLS) and fluorescence readings; involved in the method development and reports for the related analytical techniques• Determine Endotoxin concentration• Perform reduced and non-reduced SDS-PAGE and Caliper; tested different conditions and kits for comparability between methods• Perform isoelectic focusing (iCE3) and quantitative PCR (qPCR)• Role as trainer for analytical assays • Ensure accurate results entry, reporting and documentation in Symyx electronic notebook, LIMS system (DevLIMS and PD-LIMS)• Meet sample testing timelines• Follow 6S guidelines for laboratory safety, organization and efficiency Show less

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 and size exclusion using gravity and AKTA workstations; organic extraction and ammonium sulfide precipitation• Performed native and non-native gel electrophoresis and Western blotting• Tested protein folding using circular dichroism (CD), protease profiling and refolding… Show more • 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 and size exclusion using gravity and AKTA workstations; organic extraction and ammonium sulfide precipitation• Performed native and non-native gel electrophoresis and Western blotting• 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 fibrils, and protein folding/unfolding• Performed kinetic studies on enzyme activity• Extracted chromosomal and plasmid DNA and cloned DNA using PCR. Performed site-directed or random mutagenesis on genes. Utilized bacterial/yeast phenotypic selections and screens to identify mutations of interest. Southern/Northern blotting• Performed FRET and filter binding assays to assay for protein-protein and protein-DNA interactions• Trained 3 undergraduate summer students in techniques• Presented at 4 international/national meetings, 2 internal meetings and numerous departmental meetings; invited as speaker for University seminar series• Responsible for ordering reagents and consumables• Developed and instituted inventory lists for consumables, chemical and radiation supplies, as well as MSDS records, in order to comply with regulations, to promote laboratory safety and to streamline ordering Show less

Phd, Biology

Bs, Biochemistry