PRINCIPAL SCIENTIST

Role Purpose

To execute analytical activities focused on the detection, quantification, and characterization of process-related impurities in immunological drug products. This role supports method development, validation, and routine testing to ensure product safety, efficacy, and regulatory compliance. The position involves hands-on laboratory work, data documentation, and collaboration with cross-functional teams to support the development and manufacturing of biologics.

Work experience (in months)

24

Job Responsibility and key Decisions

Assay Development Execution

Perform and support immunoassays e.g., ELISA, MSD, Luminex for the quantification of HCPs, residual DNA, and other impurities.

Assist in cellbased assays using human immune cells e.g., monocytes, dendritic cells to assess innate immune activation caused by impurities.

Prepare and analyze samples from upstream and downstream process development, formulation, or stability studies.

Maintain accurate records of experiments in ELNs and follow standard operating procedures SOPs.

Data Analysis Reporting

Analyze data using appropriate statistical tools e.g., GraphPad Prism, Excel.

Contribute to technical reports, method validation summaries, and documentation supporting regulatory submissions.

Communicate results to project leads and crossfunctional teams.

Compliance Lab Support

Ensure all work complies with GLPGMP practices, lab safety protocols, and data integrity standards.

Assist with routine instrument calibration, maintenance, and documentation.

Participate in troubleshooting experiments and optimizing assays.

Selection of appropriate dilution factors, controls, and assay formats within established guidelines.

Identification of outliers, variability sources, or issues in impurity testing data.