Immunogenicity Analyst

Business Title: 102521 | Immunogenicity Analyst

Location: Collegeville, PA 19426

Job Type: Contract (11 M+)

Job Description:

As an Immunogenicity Analyst, you will be responsible for the validation and sample testing of anti-drug antibody (ADA) and neutralizing antibody (NAb) assays for use in clinical studies in alignment with therapeutic area partners. Data from this group informs patient safety and efficacy profiles of biotherapeutics in the CLIENT pipeline and helps clinical development teams make early and informed decisions for asset progression.

Job Responsibilities:

Responsible for validating bespoke immunogenicity assays to support clinical studies, delivery of robust, high-quality data packages.

Independently providing sample analysis support for clinical studies by delivering high quality data packages working in a GLP/GCP compliant laboratory setting.

Works and communicates effectively with the group and speaks up when necessary.

Performing experimental work using human serum samples in accordance with Human Biological Sample Management (HBSM), safety and data integrity guidelines.

Skills & Experience Required:

BS/MS in Biology, Biochemistry, Immunology, or related discipline.

3-5 years experience working in a pharmaceutical, biotechnology or CRO environment applying GLP regulations.

Strong laboratory hands-on experience and theoretical understanding of clinical plate-based immunoassay validation and study support using various immunoassay platforms (MSD /Singulex /Gyros) to support immunogenicity (ADA and NAb) endpoints.