Preeti Kapoor

Spearheaded end-to-end product complaint and adverse event investigations, ensuring 100% timely closure and critical risk escalations. Managed CAPA lifecycle, performed trend analyses, and authored Annual Product Quality Reviews for commercial products.

Led assay development for the CodePlex product line, supervising five direct reports and coordinating cross-functional teams. Spearheaded equipment procurement (~$1M) to establish new laboratories and developed SOPs to enhance reproducibility.

Directed clinical assay development efforts at a molecular diagnostics start-up, reporting to the VP of Operations. Authored verification and validation reports, CAPA responses, SOPs, and stability protocols, and played a key role in achieving ISO certification.

Oversaw quality operations across product lifecycles, from new product introduction to sustaining products. Conducted internal audits across four sites for division-wide ISO compliance and managed NCRs, CAPAs, and document control using Arena.

Managed a team of six in the development of biomarker assays for the Simple Plex line. Acted as a key collaborator across Bio-Techne sites and core teams, reporting regularly to senior leadership.

Conducted bench-level biomarker assay development supporting Simple Plex product innovation.

Performed testing of raw materials and final reagents, applying analytical methods such as HPLC, UV-Vis, fluorescence, luminescence, and atomic absorption. Ensured data accuracy and traceability in accordance with ISO 9001 standards and GMP practices.

Supported preclinical development through in-vitro DMPK studies and compound screening. Helped establish a new cell culture lab to support drug metabolism research and assay development.

Participated in antibacterial and antiviral drug discovery teams, conducting cytotoxicity assays and LC-MS/MS-based bioanalysis. Analyzed PK/PD data to support candidate selection and dose optimization strategies.

Supported CNS-targeted drug discovery efforts by executing radiolabeled compound assays and LC-MS/MS analysis. Contributed to enzyme- and cell-based assay development and validation across multiple pipeline programs.

Bachelor of Science in Chemistry from Boston College.