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 antibody-drug conjugate (ADC) programs- Developed and performed a colony-forming unit (CFU) assay to determine the effects of an ADC on hematopoietic stem cells in cynomolgus monkey and human bone marrow- Provided technical support for the transfer, validation and maintenance of PK and immunogenicity assays transferred to a contract research organization (CRO) to support GLP studies

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 detect NAbs directed against a fully human monoclonal anti-IGF-1R antibody therapeutic- Developed an assay to detect Cripto-1 positive circulating tumor cells using the Veridex CellSearch® platform- Assisted with validation and maintenance of assays transferred to contract research organizations (CROs)

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 matrices (retina, choroid, aqueous humor and vitreous humor)

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 for new and established procedures- Met all clinical and preclinical study interim data analysis and database lock timelines - Hired, trained and provided performance reviews for direct reports

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 actions- Performed in-house and vendor QA audits- Drafted and executed Process and Equipment Validations

Cell/Cellular And Molecular Biology

Bs, Biology; Cell And Molecular Biology