Adam Zegar

Currently manage all active studies at Q2 Laboratory in Beijing, China. This includes immunoassay-based sample analysis of Phase I-IV clinical trials. I also independently plan all method development, validation, and sample analysis in accordance with guidance documents (NMPA and FDA) and established industry best practices. Lastly, I prepare documents such as validation plans, sample analysis plans, plate maps and other critical documents in support of clinical trials.

Executed ELISAs, ECL assays, CLB assays, and other immunoassay techniques as required. Responsible for the production of quality data and documentation in adherence to timelines and maintenance of GLP functions in the lab. Provided timely communication with clients regarding progress on scientific and operational objectives.

Developed and validated immunogenicity (ADA) assays across multiple platforms. Proposed and gained support for new knowledge and technologies; independently applied basic scientific principles and performed literature searches. I was also responsible for overseeing ADA method development, validation, and sample analysis at CROs to ensure regulatory requirements (GLP/GCP) and industry practices were followed.

Responsible for the planning, performance, and scientific quality and integrity of pre-clinical and clinical trial samples, as well as providing the interpretation and reporting of results. Worked in close contact with clients as well as to establish a good and lasting working relationship. Guided analysts in the laboratory to ensure that studies are performed correctly according to the applicable protocol and SOPs.

Immunology, Biochemistry, Virology