Advanced nucleic acid based therapies (mRNA, antisense, siRNA) and delivery platforms such as lipid nanoparticles and conjugated siRNAs. Managed teams responsible for the purification, characterization and lipid nanoparticle formulation development to support mRNA and siRNA projects. Established analytics for PK studies, QC and impurity profiling, and metabolism / stability characterization. Identified critical quality attributes for siRNA, mRNA and lipid nanoparticles. Developed methodology commonly used for assessing mRNA capping efficiency and poly A tail length. Worked with CROs, CMOs and CMC team to transfer methods, scale up and optimize production of siRNA, sgRNAs, and mRNA. Lead efforts to align nucleic acid analytics in departments across Novartis Global.

• Provided technical guidance and analytical support to RNA manufacturing, QC, and process development departments by identifying process impurities and degradation products. • Created high-throughput LC-MS and high resolution MS methods to screen various RNA compounds manufactured for outside clients (Geron, Archemix, Allergan, GSK). • Developed methods for RNA sequencing (MALDI, LC-MS/MS, chemical and enzymatic digestion) to confirm sequence and identify process impurities.• Wrote QC release SOPs and criteria for the LC-MS analysis of raw materials and oligonucleotides. • Wrote LC-MS Bioanalytical and CMC sections for IND submissions.• Designed new RT-qPCR method for quantitative PK analyses that decreased costs by over 20X and method development time by 85%.