Role Objective:
To oversee the development, qualification, validation, and technology transfer of bio-assays, binding assays, and impurity assays (HCP, HCDNA, SPR, ELISA, BET). The role involves leading analytical method transfers to plant operations, coordinating CRO activities, mentoring junior research associates, and ensuring strict compliance with regulatory guidelines, GDP, and data integrity standards.

KEY RESPONSIBILITIES
- Bioanalytical Method Development, Qualification & Tech Transfer:
- Perform continuous literature reviews and monitor pharmacopeia/regulatory guidelines to evaluate analytical methodologies and provide strategic inputs.
- Design and execute lab experiments to develop and optimize bio-assays, immuno-assays, host cell protein (HCP), host cell DNA (HCDNA), Protein A ELISA, Surface Plasmon Resonance (SPR), binding ELISA, and Bacterial Endotoxin Testing (BET).
- Qualify assays for reproducibility, prepare qualification/validation protocols, Standard Analytical Procedures (SAP), and technology transfer reports.
- Demonstrate assay processes to plant operators,



observe technology transfer at manufacturing plants, and resolve post-transfer technical queries.
- Routine Testing & CRO Management:
- Perform and guide Research Associates (RAs) in testing non-GMP, non-release batches, and stability samples for internal laboratories.
- Review protocols and analytical reports from Contract Research Organizations (CROs).
- Coordinate external activities for Anti-Drug Antibody (ADA) assays, custom antibody generation, purification, and biotinylation for in-house HCP methods.
- Materials, Cell Banking & Equipment Management:
- Identify cell lines and antibody requirements; engage with vendors and supply chain teams to recommend reagents/equipment, raise Purchase Requisitions (PRs), inspect incoming materials, and manage inventory logs.
- Oversee cell-culturing, cryopreservation (cell banking), and routine passaging based on analytical testing needs.
- Manag

📌 BRL - Bio-Immunoassay - (SRA-III) (Govandi East)
🏢 USV
📍 Govandi East