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.

- Collaborate with cross-functional teams (Process Development, QC, QA, Regulatory).

- Mentor junior team members and contribute to continuous improvement initiatives.

- Participate in audits and regulatory inspections, ensuring compliance with global standards.

Qualifications

- M. Sc./M. Tech/Ph.D. in Biotechnology, Biochemistry, or related life sciences.

- 6–9 years of experience in Analytical R&D; with focus on bioassays.

. Skillset Required: bioassay, ELISA, PCR, Research development

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