The Bioassay Analyst will lead the development, optimization, qualification, validation, and routine execution of bioassays and cell-based potency assays for biosimilar products. This role is critical in ensuring analytical similarity, regulatory compliance, and robust characterization of biologics during development, process validation, and commercial manufacturing.

The position involves technical leadership, people management, GMP oversight, and cross-functional collaboration with QC, Analytical Development, Regulatory, and Process Development teams.

Key Responsibilities

1. Bioassay Development & Optimization
- Perform bioassay analysis of Drug Substance (DS), Drug Product (DP), and stability samples on a routine basis with complete and compliant documentation.
- Conduct PRS/SRS qualification and related bioassay testing activities.
- Prepare media, reagents, and other essential materials required for bioassay execution.
- Perform cell culture activities, including revival, sub-culturing, and maintenance of cell lines.
- Lead bioassay method development, method transfer, and method validation activities across multiple products.
- Conduct and oversee bioassay method transfer to QC and cross-functional laboratories.
- Support laboratory setup, equipment qualification, and continuous improvement initiatives for the Bioassay lab.
- Lead design, execution, optimization, and troubleshooting of cell-based assays, binding assays, functional bioassays, and potency assays for biosimilars.




- Oversee assay development activities including curve fitting, system suitability evaluation, and advanced statistical modeling.
- Ensure method robustness and adherence to regulatory expectations for accuracy, precision, linearity, specificity, and assay suitability.

- Assay Validation & Lifecycle Management

- Plan, coordinate, and execute method qualification, method validation, and technology transfer to QC labs.
- Provide scientific leadership for lifecycle management of bioassays from development through commercial production.
- Review and approve assay validation protocols, technical reports, and SOPs to ensure scientific and regulatory compliance

- Regulatory & Compliance Support

- Prepare, review, and contribute to key documents required for regulatory submissions, including IND, BLA, MAA, and WHO dossiers.
- Support responses and documentation during regulatory inspections and internal/external audits.
- Ensure all assay design, development, and validation strategies comply with ICH Q2, USP, FDA, EMA, and biosimilar regulatory frameworks.

- Data Analysis & Scientific Reporting

- Lead statistical analysis of potency and functional assay data using appropriate software and models.
- Review and approve raw data, assay performance summaries, trend analyses, and method monitoring reports.

Present scientific findings, assay trends, and key performance metrics to senior leadership and internal technical committees.

📌 Assistant Manager - Bioassay Analyst (Mumbai)
🏢 BioSimilar Sciences India
📍 Mumbai