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

Job Description: Assistant Manager – Analytical R&D (Bioassay)

Role Overview:
The Assistant Manager will lead bioassay development and validation activities within Analytical R&D to support biologics and biosimilars. The role requires expertise in cell-based assays, immunoassays, and regulatory compliance, ensuring robust analytical support for product development and commercialization.

Key Responsibilities:

• Develop, optimize, and validate bioassays (cell-based potency assays, ELISA, flow cytometry, etc.).

• Support analytical characterization, comparability, and stability studies for biologics.

• Prepare and review protocols, reports, and SOPs in line with GLP/GMP and ICH guidelines.

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