Scientist - Preclinical Immunogenicity II

1w1 week ago

Dr. Reddy's Laboratories

Hyderābād, IN · Full-time · INR 1,800,000 – INR 3,000,000

About this role

We are seeking a skilled, enthusiastic, and experienced Scientist to join our Immunogenicity team. This role focuses on supporting Immunogenicity Risk Assessment for complex generics and differentiated products. It spans strategy, development, and product approval across diverse therapeutic areas and global markets.

Develop and implement strategies for in-vitro immunogenicity risk assessments, including literature reviews and experiments. Independently design, optimize, and perform in-vitro assays like flow cytometry-based immune cell profiling and cell-based assays. Work with human PBMCs and established mammalian cell cultures.

Establish and validate cytokine release assays using multiplexing/ELISA techniques. Perform immune cell viability and T-cell proliferation assays with PBMCs using flow cytometry. Plan, execute, and coordinate nonclinical in-vitro studies while managing samples with cross-functional teams.

Analyze data, perform statistical evaluations, and compile reports for internal review and regulatory submissions. Prepare and maintain SOPs, STPs, study reports, and incident records. Ensure strict adherence to QMS and organizational safety standards in a collaborative environment.

Join Dr. Reddy’s Laboratories, a leading multinational pharmaceutical company with 24,000+ employees across 66 countries. Contribute to accelerating access to affordable and innovative medicines under the purpose Good Health Can’t Wait. Work in a discrimination-free, equal opportunity environment treasuring diverse talent.

Requirements

Experience in immunogenicity risk assessment for complex generics and differentiated products
Proficiency in designing and optimizing in-vitro assays including flow cytometry and cell-based assays
Hands-on work with human PBMCs and mammalian cell cultures
Expertise in cytokine release assays using multiplexing/ELISA and T-cell proliferation assays
Ability to conduct literature reviews and evaluate product risks for regulatory submissions
Skills in data analysis, statistical evaluations, and report compilation
Knowledge of study coordination, sample management, and cross-functional collaboration
Familiarity with SOP/STP preparation and QMS compliance in pharmaceutical settings

Responsibilities

Develop and implement strategies for in-vitro immunogenicity risk assessments
Conduct literature reviews, execute experiments, and evaluate product risks during development and regulatory submission stages
Independently design, optimize, and perform in-vitro assays including flow cytometry-based immune cell profiling, cell-based assays, immunological assays, and biomarker analysis
Establish and validate cytokine release assays using multiplexing/ELISA techniques
Perform immune cell viability and T-cell proliferation assays with PBMCs using flow cytometry
Plan, execute, and coordinate nonclinical in-vitro studies
Manage samples in collaboration with cross-functional teams, analyze data, perform statistical evaluations, and compile reports
Prepare and maintain SOPs, STPs, study reports, incident records, and ensure adherence to QMS and safety standards