Research Associate - YOH Research Associate working with Sanofi - Swiftwater, PA
(2025-04 - 2026-02)
Leadership role within the Bacteriology Platform, serving as the connecting point between management and laboratory analysts. Ensured laboratory activities and clinical deadlines remained properly aligned.
- Trained and coached individuals on procedures and techniques, provided quality review of scientific data and procedures, promoted an environment of quality and safety, and offered expertise in troubleshooting, problem-solving, and optimization initiatives within the team.
- Managed and supervised laboratory personnel, effectively resolving interpersonal conflicts and providing performance feedback to elevate collaboration and team dynamics.
- Modernized the 20+ year old Serum Bactericidal Assay (SBA) by supporting implementation of AI-driven automated data collection, eliminating ~4 hour manual bacterial colony counting and reducing critical clinical data turnaround by over 50%, dramatically improving laboratory productivity across the board.
- Operated different automation softwares and successfully took initiative in leading laboratory automation usage/optimization while collaborating with automation and compliance experts through qualification testing, training, and troubleshooting.
- Directed and performed experimental and non-routine testing operations including: Critical reagent concordance and expiration extension studies, Highly experimental monovalent antisera replacement testing for meningococcal specificity and QC validation criteria, Performance monitoring and validation projects, Outbreak-related meningitis testing to evaluate overall vaccine effectiveness against wild type bacterial meningitis outbreaks.
- Acted as a Subject Matter Expert on laboratory methods, procedures and techniques involved with assay, sample management, and data review processes. Presented various PowerPoints while leading team meetings to showcase innovative laboratory practices and project overviews. Successfully assisted with laboratory audits.
- Overhauled study sample management fostering greater team inclusion and collaboration.
- Authored quality items such as deviations and investigations using Qualipso with Site Quality Operations and Compliance to ensure the highest quality and integrity. Promoted adherence to all applicable quality, corporate, safety, and regulatory requirements.
Senior Laboratory Analyst - YOH Senior Laboratory Analyst working with Sanofi - Swiftwater, PA
(2023-11 - 2025-04)
Conducted clinical and non-clinical testing in a BSL-2 laboratory within Global Clinical Immunology (GCI) under GCLP and GMP regulations. Performed the Serum Bactericidal Assay (SBA) for various meningitis strains and recorded GxP Documentation with ELN systems to gather clinical study data.
- Experience with extensive pipetting, streaking of microbiological agents, sample incubation, and quality control of the assay all in compliance with established acceptance criteria.
- Oversaw project management of clinical studies and over 5,000 samples which includes retesting, tracking, and reordering through Excel, and LIMS systems to effectively and efficiently meet clinical testing deadlines and critical study completion.
- Guided efforts to simplify the Human Complement Acquisition Program (HCAP1), sourcing an alternative commercially available option which cuts company costs and time efforts. Managed thousands of human sera agents inventory, qualification, and data tracking for the HCAP1.
- Reviewed and approved hundreds of clinical data documents, logbooks, and other GxP-compliant records across paper and digital formats, ensuring data accuracy, integrity and regulatory compliance.
- Maintenance of laboratory resources to meet assigned objectives including cleaning/thawing intervals for laboratory equipment and handling of expiring reagents/proper biological waste disposal. As well as ordering of reagents and quality control material through ERM programs, labeling of thousands of testing/reagent tubes and tracking inventory.
- Captain and point of contact for safety processes and communications with the safety team for the SBA group. Contributor and pioneer to many improvements and evolutions in safe practices, including revolutionizing the microbial plate shaking assay steps significantly reducing bacterial exposure risk.
- Created a Task Planner increasing efficiency and clarity while significantly decreasing deviation occurrences. Active planner of over 10+ day-to-day activities associated with multiple analysts and projects.
