Research Associate - Cell & Gene Therapy - Quality Analyst

M.Sc./M.Tech (Specialization in any Life Sciences) with 1-5 years experience

Roles & Responsibilities

• Manage quality control studies comprising established human cancer cell lines, normal human and patient derived primary cells (blood, plasma, serum and PBMC) to support the programs by following ethical practices and QMS as per ICH compliance.
• Conduct cell-based and molecular biology tests as a part of cell therapy development, manufacture and in-process quality control for viral vectors and final product.
• Establish and carefully execute various quality control screening tools such as DNA/RNA isolation, PCR, qPCR, Flow Cytometry, ELISA and other quality testing parameters, etc. as per the guidelines and defined criteria by maintaining highest standards.
• Review and document SOPs, protocols and reports pertaining to the program requirements.
• Excellent communication to interface with internal functional departments to support the workflow of various study-related activities.
• Coordinate with manufacturing, quality assurance, supply chain teams and strictly adherence to project timelines by preserving integrity, accuracy, safety, and quality.
• Prepare and involve in compliance monitoring inspections and regulatory agency interactions.
• Provide scientific/technical due diligence support for business development activities as required.
• Able to troubleshoot experiments, analyse data and interpret scientific presentations.
• Understanding of systems and process pertaining to sterile practices, work ethics, safety, health, and environment.

Mandatory Competencies:

• qPCR, ELISA and other QC assay validation & execution.
• Excellent communication & presentation skills
• Hands on excel skills
• Good interpersonal skills