Daniel Stenzel Email & Phone Number

Oceanside, CA

Biologics potency and characterization assay development.

La Jolla, California

- Established a Bioanalytics laboratory through the acquisition and qualification of instruments and creation of SOPs - Managed laboratory equipment including the performance and scheduling of routine and preventative maintenance- Led the development and implementation of pharmacokinetic (PK) and immunogenicity assays to support the development of two.

Responsible for the development and validation of PK, ADA, NAb and biomarker assays to support clinical and pre-clinical studies.- Established a variety of assays (PK, NAb and biomarker) to support early and late stage clinical development of therapeutic biologics including antibody drug conjugates and bispecific antibodies- Developed a cell based assay to.

Directed the development, optimization and validation of ADA and PK assays, as well as the analysis of clinical and pre-clinical study specimens for multiple clients according to GLP.- Established Meso Scale Discovery (MSD) platform testing capability in the lab- Designed an assay to quantify the levels of a monoclonal antibody in various rabbit eye.

Supervised, coordinated and reviewed PK and Immunogenicity analysis of clinical and pre-clinical study specimens by ELISA method according to GLP.- Monitored the performance of assays and performed troubleshooting as needed- Established procedures for, as well as executed and reviewed, the qualification of new reagents- Drafted, revised and reviewed SOPs.

Designed and enhanced new and established autoimmune disease diagnostic products (ELISA and IFA) according to GMP- Assisted with the transfer and optimization of a Luminex based assay from research to manufacturing- Performed investigations of non-conforming products and product complaints, in order to determine appropriate corrective and preventative.

Cell/Cellular And Molecular Biology

Bs, Biology; Cell And Molecular Biology