Julie A. Email & Phone Number

• Executive Director 2023 - present (Pharmaceutical Sciences Program Leadership)
• Pharmaceutical Sciences leader for key gastrointestinal (GI) disease asset, responsible for providing strategic scientific leadership to Pharmaceutical Science teams. Responsible for planning, coordination, and.
• Represent Pharmaceutical Sciences at the Global Program Team, responsible for identification, mitigation, and communication of project risks to stakeholders for collaborative, effective decision making
• Manager of Pharmaceutical Sciences leaders. Responsible for scientific leadership, budget planning, scenario planning, strategic planning, and execution of CMC deliverables across a portfolio of molecules, spanning.

• Manager of an analytical group responsible for analytical method development and strategy for synthetic molecule projects (early stage through late stage) across oncology and GI therapeutic areas

Cambridge, Massachusetts

• Project leader for a Phase 1 oncology project, responsible for strategic leadership and project management of the Pharmaceutical Science team
• Manager of scientists responsible for analytical method development and strategies for synthetic molecule projects (early stage and late stage), across oncology and GI therapeutic areas

• Manager of scientists responsible for analytical method development for synthetic molecule oncology projects
• Key participant in EOP2 and pre-NDA briefing book preparation and meetings with FDA, responsible for defining analytical strategy for the oncology asset
• Authored analytical sections in regulatory submissions (IND/IMPDs/NDA) across multiple regions (US, EU, Japan, China) and defended analytical strategies in response to questions from Health Authorities

• Hands on development expertise with dissolution, HPLC/UHPLC, LC-MS, Karl Fischer, and particle size analysis (laser diffraction and image based)
• Executed phase appropriate analytical method validations, method transfers, and specification setting for small molecule drug substances and drug products in oncology
• Responsible for oversight of CMOs/CROs for analytical development testing

• Utilized ESI FT-ICR mass spectrometry for biomolecular structural characterization.
• Extended the applications of ion-electron based MS/MS, including ECD and EDD, for protein and oligosaccharide structural analysis.
• Additional experience: LC/MS of peptides and oligosaccharides, nanospray-ESI, and interpreting peptide and oligosaccharide MS/MS data.

Phd, Analytical Chemistry

Graduate Certificate In Biopharmaceutical Domestic Regulatory Affairs, Regulatory Affairs

B.S., Chemistry

Bachelors in Chemistry