job summary:
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.
location: Collegeville, Pennsylvania
job type: Contract
salary: $40.00 - 43.55 per hour
work hours: 9 to 5
education: Bachelors
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.
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.
skills: Biology, GLP (Good Laboratory Practice), GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.