Validation Scientist

Pharmacokinetic Validation Team Member

The incumbent will work as part of the validation team to support all validation and life cycle activities of Pharmacokinetic (PK), Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) assays for the development of biological drugs.

Key Responsibilities/Essential Functions

• Coordinate, plan, and execute NAb and/or ADA assay validations by actively collaborating with team members from method development group to deliver validated methods for bioanalysis support.
• Support immunoassay and cell-based assay platforms with laboratory skills to execute experiments when needed.
• Provide input and identify problems with scientific experiments, analyses/tasks in related areas.
• Produce documents to support PK, ADA and NAb assay validations

Qualifications

• M.S. with 2-4 years of experience or a B.S./B.A. with 3-6 years of experience in Biology or related field.
• Experience with immunoassay and cell-based assays used in the ADA, NAb, or PK bioanalysis of biologic drugs is highly preferred.
• Experience in a GxP environment is required.
• Prior experience in pharmacokinetic and ADA bioanalysis and method validation is preferred.
• A high level of computer proficiency in Microsoft Office suite and writing skills is required.
• Experiences with automated data analysis, electronic lab notebook, Watson Laboratory Information System, AI tools, and statistical tool.
• Excellent communication skills and the ability to perform effectively in a fast-paced environment required.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

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