BRL - Bio-Immunoassay - (SRA-III)
MaharashtraFull-time5–9 yrsPosted over a month ago
Senior pharma role at USV in Maharashtra. Needs 5+ years and an M.Tech, M.Sc or PhD.
About the role
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.
What you'll do
- 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
- Demonstrate assay processes to plant operators, observe technology transfer at manufacturing plants, and resolve post-transfer technical queries
- 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)
What you need
- CRO
- Compliance
- Audit
- Coordination
- GMP
- SOP writing
Good to have
- SAP