Abby Schaeffer Email and Phone Number

●Evaluating test procedures and analytical results for regulatory and SOP compliance. ● Managing scheduling, inventory, and training of junior staff of at least 12 people. ● Supporting audit preparation, resolution of quality issues and acquisition of equipment. ● Supporting new workflow and process improvement initiatives such as ELN implementation and cross-disciplinary collaborations ● Coaching staff on performance, health and safety protocols, and career growth. ● Fostering teamwork and interdepartmental communication to enhance operational outcomes and employee retention.

●Executed laboratory procedures for tissue and oligonucleotide analysis for preclinical and early phase trial support with strict adherence to good laboratory and clinical practice. ● Prepared experiments and for qualitative and quantitative analysis of clinical samples for ADME and DMPK studies. ● Analyzed results and reported findings to facilitate root cause analysis meetings and drive project success. ● Documenting all procedures accurately in accordance with customer specifications. ● Taking on additional responsibilities to support laboratory operations, including Hamilton STAR troubleshooting and optimization, recommending process enhancements for other lab teams, and contributing to the validation and refinement of new analytical methods to improve accuracy and efficiency.

● Performed biomarker, biotherapeutic, and small molecule purification using immunoassay, solid-phase, supported solid-phase, and liquid-to-liquid extraction techniques, with a focus on accuracy and quality. ● Integrated Hamilton Star automation and specialized laboratory equipment into pre-existing analytical methods, improving the percentage of rework and enabling faster data delivery. ● Applied process improvement skills to streamline lab workflows, enhancing efficiency and reducing error rates. ● Collaborated with cross-functional bioanalytical groups, including LC/MS teams, to support biomarker testing and quantitation for large and small molecule assays, as well as multiplex LC/MS assays. ● Contributed to quality initiatives using Lean Six Sigma Yellow Belt principles to maintain data integrity and optimize lab operations.

●Ensures the quality of outgoing raw materials and reagents by performing analytical testing on Rheonix Encompass and Encompass MDX Workstations and other analytical equipment●Completing analysis of data using Microsoft applications and other internal forms to report test results in compliance with the FDA●Participating in the development and validation of analytical methods, conducting laboratory duties to include sampling, testing, data evaluation and analysis on samples ●Preparing test samples, reagents, and primers for testing according to microbiological procedures ●Provides accurate release data to confirm product performance meets specifications and to make improvements in procedures and materials●Finalizing laboratory investigations, quality investigations and other internal forms in response to trends in a timely manner ●Administers training new personnel regarding company operations, quality investigations and records and proper Biosafety level 2 training ●Responsible for delegating, executing, and formulating an organized approach to tackling multiple assay development and quality control tests within a specified period

●Work week averaging 20-30 hours while maintaining a 16-credit hour course load ●Actively involved in merchandising presentation●Stocked, replenished, organized store merchandise, as well as merchandise presentation ●Provided complete solutions to concerns and questions using exceptional customer service, and communication ●Trained and provided advice, leadership, and management to new and existing associates

●Used this position as a second form of employment averaging 10 hours a week while managing 16-credit course load ●Answered public phone calls in regard to any university matter using accurate and complete information ●Provided necessary details to callers regarding comments or concerns involving the University within compliance of Federal law and maintaining the integrity of the Binghamton University Campus