Sr. Assay Validation Specialist

Sr. Assay Validation Specialist
Company:

Zachary Piper Solutions, Llc


Sr. Assay Validation Specialist

Details of the offer

Piper Companies
is looking for a
Sr. Assay Validation Specialist
to be responsible for overseeing the design and implementation of immunological assays validation and qualification for a Therapeutic manufacturer in
Philadelphia, PA
.

Responsibilities for the Sr. Assay Validation Specialist

include:
• Design and Develop immunological assays validation/qualification
• Review/Author assay qualification technical protocols and reports
• Author technical documents such as SOPs and assay work sheets
• Create templates and formatting documents using Microsoft Office tools
Qualifications for the Sr. Assay Validation Specialist

include:
BS/BA or higher in relevant scientific discipline (immunology, health care, life science, biology, biochemistry, etc.)
Strong background in testing preclinical and clinical samples with various immune assays
At least 5 years of immunological assay validation/qualification in a regulated environment;
Excellent understanding of biological assays such as Neutralizing Antibody Assay, ADA, ELISA, ELISPOT, cell-based assays, qPCR assays, etc.; Hands-on experience running these assays preferred, but not required;
Extensive knowledge of statistical tests applied to bioanalytical assays
Technical writing experience with the ability to provide work examples of such experience;
Solid knowledge of GLP/GCP, Good Documentation Practices and regulatory guidance;
Excellent written and verbal communication skills.
Compensation for the Sr. Assay Validation Specialist

include:
• Direct Hire/Permanent Opportunity
• Salary Range: $80,000 - $85,000 + Bonus
• Up to $270/month travel stipend


Source: Dice


Area:

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