AM- Analytical R&D-Bioassay
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
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
./ in Biotechnology Biochemistry or related life sciences.
6–9 years of experience in Analytical R&D with focus on bioassays.
Required Skills:
bioassay ELISA PCR Analytical R&D Research development
