Led clinical PK, PD and immunogenicity assay life cycle management from early stage to registration. Worked directly with CROs and clinical team to support clinical trials and regulatory submissions. • Clinical trial conduct within the scope of Clinical Bioanalytics including but not limited to: ◦ Clinical trial documents including study protocols and regulatory documents such as CSR and ISI. ◦ Sample reconciliation, data review/QC and providing files for data base lock activities. ◦ Selection, qualification and evaluation of CROs and central laboratories. ◦ Creation and addition of documents and QC review of documents for trial master files. • Key contact with external and internal laboratories including central laboratories. • Maintaining compliance to internal SOPs and regulatory policies. • Transfer of PK and immunogenicity assays from internal labs to CROs, assisting in troubleshooting and resolution of bioanalytical assays as necessary.

Established bioanalytical strategy and project support priorities for clinical and preclinical assay development, in-house validation and sample analysis, and transfer of projects to CROs as a bioanalytical principal investigator. • Supervise or independently design, develop and validate LBA on MSD and Gyrolab platforms or cell-based assays with or without beads (ACE, BEAD, SPEAD) for both clinical and preclinical programs to measure compound concentrations or detect anti-drug antibodies (ADA) and Neutralizing anti-drug antibodies (NAb) in various matrices in a regulated environment. • Ensure all assays meet federal regulations and reports are submission ready.• Transfer assays to a suite of different CROs and ensure successful validation at CROs. • Interpret results, draw conclusions, and make appropriate decisions to drive projects forward, meet timelines, and maintain GLP and GCLP compliance. • Work within Watson LIMS to generate validation and sample analysis tables for reports. Prepare submission ready bioanalytical procedures, validation reports, and sample analysis reports.

Independently developed LBA for quantitation of compounds and detection of anti-drug antibodies and neutralizing anti-drug antibodies in serum and plasma.• Independently design, develop and validate LBA on MSD and Gyrolab platforms with or without beads to measure compound concentration and detect anti-drug antibodies and neutralizing anti-drug antibodies in serum or plasma in a regulated environment to support the portfolio.• Supervised junior staff for the development of LBA on MSD to support the portfolio and functioned as direct resource for staff to ensure appropriate support is in place and executed.• Perform sample analysis on validated LBA for both clinical and preclinical projects.• Collaborate with colleagues and/or train colleagues to drive projects forward.• Interpret results, draw conclusions and make appropriate decisions to drive projects forward while following departmental SOP and maintaining GLP and GCLP compliance.• Perform retrospective QC review on past studies to ensure audit ready.• Work within Watson LIMS to generate validation and sample analysis tables for reports. Write bioanalytical procedures, validation reports, and sample analysis reports.

Developed LBA for quantitation of drugs and detection of anti-drug antibodies and neutralizing anti-drug antibodies in human serum and plasma. • Design and develop LBA on both MSD and Gyrolab to measure compound concentrations and detect anti-drug antibodies and neutralizing anti-drug antibodies in serum and plasma in a regulated environment.• Collaborate with colleagues to drive project forward and meet timelines.• Interprete results and make appropriate independent decisions to drive the assay forward.• Work within Watson LIMS for validation and sample analysis.

Developed LBA for quantitation of drugs and detection of antibodies and neutralizing antibodies in human serum and plasma. • Designed and developed LBA in cooperation with colleagues to detect anti-drug antibodies in plasma and serum through electrochemiluminescent (ECL) detection on the Meso Scale Discovery (MSD) platform in a regulated environment.• Performed data analysis and interpretation of LBA.• Maintained electronic notebooks.• Adhered to GCLP and GLP in the laboratory, followed federal regulations.

Supervised a team of scientists performing nonclinical studies according to protocols, SOPs, and regulations. Managed manufacturing of kits used for the induction of nonclinical autoimmune models. • Manage quality control, kit production, and integration of new material lots into production. • Perform LBA, microscopy, and cell culture. • Extensive biological sample handling, processing, and analysis. • Expand services through the development of additional nonclinical models and assays. • Execute preclinical autoimmune and inflammatory models including EAE, CIA, DTH, and colitis. • Administer compounds via IV, oral, IP, subcutaneous. • Train employees in protocols, kit manufacturing, and laboratory processes including LBA, isolation and staining of cells for flow cytometry, and spleen and lymph node stimulation in culture.

Taught anatomy and biology labs and assisted in eukaryotic cell and developmental biology class.•Organized and gave lab lectures•Generated and administered practicals encompassing material from human anatomy to cellular biology

Studied mutation of mortalin in cancerous clam cells•Performed western blots to detect proteins, antibody reactivity and specificity•Executed polymerase chain reactions followed by electrophoresis, ligation and transformation in E. coli•Quantified DNA and RNA concentrations

Studied the degradation of foam•Performed daily laboratory procedures on dialysis bags for polymer diagnosis•Analyzed components of substances via HPLC•Evaluated the degradation of foam via UV spectrum