Immunogenicity Analyst

Immunogenicity Analyst

10 Months (Possibility for Extension)

Collegeville, PA

Max PR: $43.55/hr

Shift: Monday-Friday 9:00am-5:00pm. - 100% ONSITE

Required:

• Min of BS 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.

Preferred:

• Master’s Degree in Biology, Biochemistry, Immunology or related discipline

Interview Process:

• Pending Information

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 company pipeline and helps clinical development teams make early and informed decisions for asset progression.

Job Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Education & Qualifications

We are looking for professionals with these required skills to achieve our goals:

• 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.

• Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence.

• Attention to detail and good communication and documentation skills will be expected.