Validation Scientist

Our large pharmaceutical client is seeking a Lab Scientist to join their growing Bioanalytical Discovery & Development Sciences team in Spring House, PA. This Scientist will work as part of the immunogenicity assessment team to support all validation and life cycle activities of Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) assays for the development of biological drugs. This group is responsible for developing, validating, and conducting bioanalytical methods related to large molecule biotherapeutic drug development across all therapeutic areas of their spanning nonclinical studies to post-market clinical development.

Responsibilities include:
- Coordinate, plan, and execute ADA and NAb 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 ADA and NAb assay validations
- Take data generated in the lab and compose SOP, validation plans, and validation reports

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Required Skills & Experience
- M.S. with 2+ years of experience or a B.S./B.A. with 3+ years of experience in Biology or related field
- Prior experience in Anti-Drug Antibody (ADA) and/or Neutralizing Antibody (NAb) assay method development and validation
- Experience with immunoassays and cell-based assays used in the ADA and NAb bioanalysis of biologic drugs
- Experience with composing SOP, validation plan, and validation reports
- Excellent communication skills and the ability to perform effectively in a fast-paced environment

Nice to Have Skills & Experience
- Experience in a GxP environment
- Experience with automated data analysis, electronic lab notebook and statistical tools

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.