Jackie O'Neil Email & Phone Number

Boston, MA, US

Boston, MA, US

Cambridge, Massachusetts, US

• Collaborate with research team to optimize contracts (saving ~$100K/annual), business processes (saving 5-10% internal FTE hrs), and working tools (saving additional 5-10% internal FTE hrs)
• Identified and reduced internal redundancies through internal CRO management team formation to develop optimized informatics tools and harmonize ways of working, reducing total time spent managing CROs 10-25% by.
• Streamline research activities, saving > $400K in 2023 by optimizing assay workflow funnel
• Improve speed, quality, and cost transparency across discovery CRO network through establishment of harmonized operations, quality metrics, and cost comparisons
• Perform external resource risk assessment, allowing organization to ID and prepare against highest areas of risk to programs and on-time delivery of externalized research
• Developed CRO reward program to identify, support, and reward top external scientific talent

Building Extraordinary Client & Supplier Relationships and Next-Generation Business Processes

Cambridge, MA, US

• Responsible for management of all contract research, development, clinical, and commercial manufacturing network for Auryxia®(ferric citrate) and Vafseo®(vadadustat), ensuring supply chain operational goals are met and.
• Group Leader of 5 FTEs with focus on supplier relationship management (SRM) development, manufacturing, pack/label for two programs across 10 global sites
• Oversee CMO execution and performance, conducting quarterly business operations meetings, monitoring and gathering data to enable calculation of Key Performance Indicators (KPIs)
• Implemented robust project management tools to increase efficiency of meetings, reduce email burden, and report transparent metrics, ensuring projects are delivered on time, in budget, with high quality standards for.
• Designed and built integrated database and automated KPI reporting tools to monitor supplier performance, roll up metrics, and ensure automated reporting activities at suppliers globally
• Strong leadership, team building, organizational, communication and interpersonal skills to build relationships with functions including Quality, Regulatory, Supply Chain, Technical Operations, Finance, Sourcing.

Cambridge, MA, US

Cambridge, MA, US

Dublin, IE

• Responsible for optimizing form behavior of novel APIs and salts to obtain higher purity to allow for key experiments through total fundamental physical characterization of discovery molecules
• Designed isolation/crystallizations of novel molecules to initialize discovery in vivo studies
• Developed high-throughput screening experiments for physical form screening, solubility determination, single crystal growth experiments.

Dublin, IE

• Designed, developed and transferred improved GMP crystallizations for LYBALVI® program
• Implemented new process chemistry and optimized operational GMP manufacturing processes for process validation, increasing final API yields and purities
• Elucidated solid forms of samidorphan, diorexel fumarate, and many discovery compounds
• Method development for HPLC and UPLC assay content and impurity quantitation
• Multi-factorial Design of Experiments (DoE) for reaction engineering optimization
• Analytical development and support for Raman, IR, and Particle Size Distribution (PSD) methods

Dublin, IE

• Optimized synthetic intermediate processes, increasing yields and purities, allowing for higher yields and purities of final API drug substance
• Completed solubility determination, physical form characterization, and crystallization development for key synthetic intermediates and final API drug substances
• Developed toxicological/preclinical formulations for oral, subcutaneous, and intramuscular dosages
• Formulation development and new excipient evaluation and qualification for Aristada® drug product
• Analytical measurement for particle size distribution, injection force, and formulation stability

Dublin, IE

• Preclinical and Phase 1 formulation development of Aristada® drug product
• Physical characterization and initial stability assessments of API and drug product excipients
• GLP API Particle Size Milling to supply toxicology studies for Investigation New Drug application
• CRO Technical representative for formulation support and in life GLP Toxicology dosing

Boston, MA, US

-Synthesized anti-Alzheimers and Parkinsonian drugs for radio labeling-Optimized conditions for novel reactions including microwave-assisted reactions-Purified reaction products using silica gel/flash chromatography-Analyzed reaction products using GC/MS, NMR and HPLC

Boston, MA, US

-Performed functional MRI (fMRI) and Single Photon Emission Computed Tomography (SPECT) scans for research-directed imaging -Imaged awake animal subjects for stress and drug-related studies-Developed good animal husbandry skills and comfort with animal surgeries, anesthesia, and handling of mice, rats, and primates

Columbia, Maryland, US

-Assisted with set-up, customization and implementation of a new web-based software-Coordinated chemical data for an international acquisition, catalogued all new chemical materials across multiple sites and information systems-Coordinated chemical data for all new raw materials and authored internal documentation for safe handling for coded materials

Ms, Chemistry

Bachelor And Master Of Science Degrees, Chemistry