Heather Walters

Analytical Method Transfer & Validation: Development and Validation of cell- and plate-based assays; method troubleshooting and optimization; preparation and review of data tables, protocols, and summary reports

Regulated Laboratory Operations: GMP/GLP/GDP compliance; change control, OOS/OOT investigations, CAPAs, and regulatory compliance (ICH, EMA, FDA)

Bioassay Techniques: immunology assays including: immunofluorescence microscopy, flow cytometry, western blotting, and plate-based readouts (ELISA, MSD, Elispot); cell culture and maintenance)

Quality Systems & Documentation: SOP review; data integrity; inventory and procurement management; use of quality systems for deviation management and document control; use of various LIMS for sample management and data entry

Cross-Functional Collaboration: client communication, program management, and cross-disciplinary teams for project scoping and milestone achievement

Software & Systems: MS Office Suite (Word, Excel, PowerPoint, Outlook), GraphPad Prism, Adobe Illustrator, Photoshop, Acrobat, Buyways, NetSuite, LIMS, Smartsheet, QMS

Data Analysis, Biostatistics Reporting: Data presentation, biostatistical evaluation, preparation of technical reports, peer-reviewed publications, and regulatory documentation Proficient in generating standard curves, R² values, and error analysis to assess assay accuracy and reliability

Project Management: Translating complex scientific concepts for diverse audiences; Resource planning, procurement oversight, and vendor management; preparing project updates, technical summaries, and client-facing deliverables

QC and Manufacturing Experience: GMP/GLP/GDP-compliant analytical testing; Quality control assays on raw materials, intermediates, and finished products; Collaboration with cross-functional teams to resolve to maintain manufacturing timelines