Immunogenicity Analyst - Contract - Collegeville, PA
Proclinical is seeking a dedicated Immunogenicity Analyst. This is a contract position located in Collegeville, PA.
Primary Responsibilities:
In this role, you will be validating and testing anti-drug antibody (ADA) and neutralizing antibody (NAb) assays for use in clinical studies. Your work will contribute to the understanding of patient safety and efficacy profiles of biotherapeutics, aiding clinical development teams in making informed decisions for asset progression.
Skills & Requirements:
A degree in Biology, Biochemistry, Immunology, or a related discipline.
Experience in a pharmaceutical, biotechnology, or CRO environment with a strong understanding of GLP regulations.
Hands-on laboratory 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.
A disciplined approach with a focus on quality, compliance, scientific rigor, and operational excellence.
Attention to detail, good communication, and documentation skills.
The Immunogenicity Analyst will:
Validate custom immunogenicity assays to support clinical studies, ensuring the delivery of robust, high-quality data packages.
Independently provide sample analysis support for clinical studies in a GLP/GCP compliant laboratory setting.
Communicate effectively within the group, voicing concerns when necessary.
Perform experimental work using human serum samples, adhering to Human Biological Sample Management (HBSM), safety, and data integrity guidelines.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1)267-846-2026 or j.cerchio@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.