Kaitlin (Kaity) Gonzalez Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, Us

Supports the Clinical Biomarkers laboratory phase 1 & 2 studies by Independently conducting experiments for various assay platforms including: Flu (HAI), NK Engager (ELISA), and Mpox (MSD). Developed and qualified/ validated multiple assay projects and trained junior RAs. Lead of the Special OPS Safety Committee.• Developed the Laboratory Safety Walkthrough Checklist and committee charter.• Developed a Master Tracker for project and resource management that has been used across most assay teams.• Co-Tech Lead of 2 clinical studies and Technical Lead of 2 clinical studies from assay development to sample testing.• SME for the development of the first end-to-end automation HAI assay for Moderna and Phase 2 study live virus.

Develops, improves, and monitors the activities and resources related to implementation and maintenance of effective quality systems including but not limited to: document control, CAPA related issues, calibration certification authoring, invoicing, quotes, and internal and regulatory audits and inspections. Institutes best-practice procedures for compliance and risk mitigation utilizing ISO 17025 and ISO 9001 guidelines.• Leads system migration for all documentation from paper to digital system• Employs Six Sigma tools & techniques for maximization of workflow efficiencies during new company acquisition and bring continuous improvements• Authoring and revising SOPs for a new a quality manual • Coordinates efforts leading to the acquisition and maintenance of appropriate accreditations, licenses and certificates relevant to the industry

Paris, France, Fr

Supports R&D: Global Clinical Immunology department with clinical studies for Influenza vaccine development through ELISA testing, via microneutralization and hemagglutination inhibition assays, as well as MDCK cell culture. Assigned testing in BioSafety level 2 lab using single and multi-channel pipettes, centrifuges, waterbaths, plate washers, biological safety cabinets, and more. Daily maintenance, calibration, and cleaning of equipment. Executes daily transactions in relevant cGMP computer-based systems (NuGenesis, LIMS, Softmax, SUE, etc.). Assist in management of colleagues’ daily tasks and overall lab flow. • Created and manages multiple inventory & tracking systems including: clinical sample inventory, testing assay tracking, sample retest tracking, and stock inventory.• Subject matter expert in the Phase 1 & 2 implementation of the department electronic +QDCI board for performance tracking, in less than 7 months.• Championed the use of automation by innovating an optimized method for LIMS sample scanning using QR codes, increasing the clinical testing department’s efficiency by 400+% and utilized cross-functionally in the data and systems team for use in SQL*LIMS and StarLIMS.

Philadelphia, Pa, Us

*Contracted to Sanofi Pasteur

Philadelphia, Pa, Us

*Contracted to Sanofi Pasteur

Heerlen, Limburg, Nl

Conducted Wet Chemistry tests and investigated OOS results for 4 labs. Analyzed raw materials, intermediates, stability samples and finished products. Prepared standards, mobile phases, and all necessary reagents for daily testing. Maintained, monitored, and calibrated lab equipment. • Streamlined lab books, in adherence with cGMP, reducing lean manufacturing wastes. • Performed Gage R&R with 3 analysts, determining method and process variability.• Significantly increased productivity by implementing a visual management system. • Cross-trained on-boarded analysts, increasing hands-on-deck across products & reducing TAT. Part of both the Quality Culture Site Team and Site Sustainability Team

University Park, Pa, Us

• Fingerprint scanning using the 3M Cogent CS500e Tenprint LiveScan in a non-criminal environment for the purposes of background checks• Fingerprint collection using fingerprint cards• Fingerprint analysis with the help of software as well as manual skills

University Park, Pa, Us

• Research efforts published in Scientific paper • Manipulated thousands of plant images for Google’s Deep Learning program• Organized database of 153 crops & 2,000 plant disease photos & information crop disease detection

State College, Pennsylvania, Us

Navigated effective virtual and face-to-face discussions on race, culture, and global issues. Contributed 8K+ hours in fostering a safe environment for participants’ dialogues.• Incorporated video teleconferencing for NATO cadet training, promoting military-civilian collaborations.• Led 2-day, CIC Summit 3.0 integration practice workshops for 100+ top university students.

Project Management

B.S, Science - Class Of 2016