- R&D Bioassay

About Client:
Leading Biopharma client having Biopharma API and Formulations Business across regulated markets.

Position: Bioassay R&D

Key Responsibilities:

• Lead development optimization and validation of bioassays and analytical testing methods for biologics/biosimilars.
• Hands-on/technical expertise in ELISART- PCR/PCR HCP (Host Cell Protein) residual DNA potency binding and functional assays.
• Develop and optimize HCP ELISA residual host-cell DNA testing protein concentration and impurity assays.
• Design and execute cell-based bioassays ligand-binding assays reporter gene assays and immunoassays for potency and biological activity.
• Perform PCR/PCR-based testing for residual DNA microbial/viral targets or other relevant molecular assays.
• Conduct assay method development optimization qualification validation robustness and method transfer.
• Troubleshoot assay failures variability OOS/OOT results and perform root-cause investigations and CAPA.
• Review and interpret analytical data and ensure compliance with ICH GLP/GMP and regulatory requirements.
• Lead documentation including SOPs protocols analytical methods validation/qualification reports and study reports.
• Mentor scientists and coordinate bioassay testing activities timelines and laboratory resources.
• Collaborate with Analytical R&D QC CMC Regulatory and Manufacturing teams for product development and regulatory submissions.