Mary Bright

Responsible for evaluating new technologies and assays used in developing gene therapy focused on rare and orphan genetic disease research. Authored key documents and presented findings to support informed decision-making for product technical development to ensure FDA compliance. • Supported cross-functional process development by analyzing and reviewing data to meet timelines and deliver results to stakeholders. Contributed to assay development and optimization while training analysts, fostering collaboration and knowledge sharing. • Investigated the discrepancies of the CE-SDS assay results based on findings over time via Design of Experiment (DOE) analysis which identified statistically significant factors. This identified the optimal conditions for the assay which led to prequalification and transfer to the manufacturing partner. • Evaluated new technologies and assays by attending industry webinars/seminars and building industry relationships. This enabled the team to learn about new technologies and investigate how these innovations could benefit the company relative to the costs of utilizing or purchasing them.

Responsible for supporting the process development of gene therapy focused on rare and orphan genetic disease research. Authored key documents and presented findings to support informed decision-making for product technical development to ensure FDA compliance. • Leveraged expertise to manage tasks in a new environment, enabling the team to focus on assay development and their core responsibilities. • Assumed responsibility for two assays in a non-GMP toxicology stability study to support team needs. Conducted investigational testing on of the assays followed by a pre-qualification and documented the troubleshooting process and findings in a comprehensive report. This ensured the study remained on schedule and provided the team with deeper insights into both the assay and the product. • Gained competency in new assays to support a cross-functional team and reduce a backlog of process development samples. This effort helped balance workloads across the team and ensured timely delivery of results to the process development group.

Responsible for supporting the process development and qualification of assays for clients in the biologics industry. Authored key documents and interacted with cross-functional teams to ensure timelines were met. • Gained competency in new assays and honed previously acquired skills to efficiently support client programs. This enabled even workload distribution and continuous movement of programs forward. • Conducted and reviewed qualifications, drafting reports in collaboration with team members at a different site. This ensured assays were prepared for GMP testing, advancing products toward patient care. • Collaborated on the development and optimization of assays for new and existing client programs, facilitating skill enhancement and supporting critical decision-making for clients.

Performed GMP testing for biologics-specific client programs using various instrumentation methods. Reviewed data, trained analysts, and engaged in client meetings to ensure timely project progression. • Ensured a seamless transition and uninterrupted data delivery by maintaining a strong relationship with a client after the project lead's departure, leveraging expertise with their assays to provide continuity and support. • Trained analysts on complex assays, conducted detailed data and report reviews, and executed advanced analyses for diverse client-specific programs. This ensured seamless execution of analyses and uninterrupted data delivery during staff absences. • Led the Activities Committee, organizing and hosting site-wide and team-specific events to promote engagement, strengthen team cohesion, and foster camaraderie across the organization

Performed GMP HPLC testing and prepared solutions for biologics-specific assays. Supported client programs by reviewing data, participating in client meetings, and providing training to analysts to maintain project continuity. • Completed intensive GMP and HPLC training tailored to a specific client, resulting in streamlined assay execution and data review processes, ensuring on-time delivery of project milestones.

Responsible for analytical testing of company products to support the development team. Performed sample analysis, calibration of instruments, and general laboratory upkeep. • Conducted testing of latex and adhesive samples using various instruments, ensuring proper maintenance for accurate and timely data delivery to the development team.

Responsible for reviewing, filing, and organizing batch records, assisting with label making for manufacturing batches and general office work. • Collaborated in a cross-functional Kaizen event to improve batch record filing, resulting in a more efficient system that reduced filing time and enabled focus on higher-priority tasks.