Job Summary:We are seeking a Scientist with expertise in plate-based process impurity assays to support biologics programs. This role will focus on the development, qualification, troubleshooting, and transfer of ELISA-based assays for detecting Host Cell Proteins (HCP), residual Protein A, residual DNA, and other process-related impurities. The ideal candidate will have hands-on experience in assay development and validation, strong analytical problem-solving skills, and the ability to collaborate with cross-functional teams.Key Responsibilities:1. Assay Development & Qualification (50%)Develop, optimize, and qualify plate-based impurity assays (e.g., ELISA, qPCR, Western blot) for process impurity detection.Evaluate assay performance, ensuring sensitivity, specificity, accuracy, and precision meet regulatory expectations.Conduct method qualification and contribute to validation strategies in compliance with ICH and USP guidelines.Support the development of custom and commercial HCP ELISAs, including reagent assessment and selection. 2. Assay Troubleshooting & Remediation (30%)Investigate assay variability, drift, and reagent stability issues to ensure robust impurity testing.Work with internal teams and external vendors/CROs to assess critical reagents and optimize assay performance.Provide technical expertise in resolving lot-to-lot variability issues in impurity assays.Analyze and interpret assay data, preparing technical summaries and reports. 3. Technology Transfer & Regulatory Support (20%)Support the transfer of impurity assays to QC labs and external CRO/CDMO partners.Prepare technical reports, regulatory submissions, and responses to health authority queries.Participate in cross-functional meetings to ensure alignment on impurity assay strategies.
