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 ELISA,RT- 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.

📌 Sr.manager- R&D Bioassay (India)
🏢 Talental Consultings
📍 India