Working within the Genomic Medicine Unit (GMU) Analytical Development department on analytical method development in support of pre-clinical and clinical trial materials testing on novel gene and cell therapies, including bioassays, immunoassays, and viral infectivity. Engaging in data and program management for high-priority programs, interfacing with Quality Assurance, Stability, and Documentation personnel, including addressing audit reports and other GMP compliance aspects, including a department-targeted GMP training program. Frequent drafting of method-based technical reports, procedural documents, compliance guidelines, and method qualification reports, as well as sophisticated Excel spreadsheets automating assay analysis and suitability assessments, with accompanying technical reports supporting spreadsheet verification.

Worked within the Bioanalytical Development department on analytical method development in support of pre-clinical and clinical trial materials testing for novel enzyme, antibody, and gene therapies,, including bioassays, immunoassays, and viral infectivity. Engaged in data and program management for high-priority programs, interfacing with Quality Assurance, Stability, and Documentation personnel, including addressing audit reports and other GMP compliance aspects. Developed a department-targeted training module for GMP Documentation practices. In addition to method-based technical reports, procedural documents, compliance guidelines, and method qualification reports, drafted technical documentation in support of Excel spreadsheets automating assay analysis and suitability assessments.

Worked within the Bioanalytical Development department on analytical method development in support of pre-clinical and clinical trial materials testing for novel enzyme, antibody, and gene therapies,, including bioassays (cell-based potency, ELISA), viral infectivity, and Biacore. Engaged in data and program management for high-priority programs, interfacing with Quality Assurance, Stability, and Documentation personnel. Responsible for drafting or revising of procedural documents, study protocols, technical reports, and qualification/validation reports.

Worked within the Bioanalytical Development department on analytical method development in support of pre-clinical and clinical trial materials testing, including cell-based potency, ELISA, Biacore, and gel-based methods; drafted procedural documents in support of method development.