Role Objective: Will work in the Analytical Development Lab of BRL, taking responsibility for the analytical deliverables of Biologics Projects for all markets. Deliverables involve, but are not limited to, Method Development, Qualification, Technology transfer, Biosimilarity assessment, Forced degradation, and Characterization activities.

Key Responsibilities

Responsible for the independent planning and execution of experiments, with a major focus on Mass Spectrometry, HPLC, UPLC, and CE-based analysis.
Apply analytical techniques including, but not limited to, Chromatography, Electrophoresis, Spectrophotometry, and Colorimetric assays for Biotherapeutics.
Perform assigned analytical activities by following established systems and procedures.
Maintain target dates for all assigned analytical activities.
Maintain strict data integrity during all analysis processes.
Prepare and review technical reports and contribute directly to troubleshooting efforts required for laboratory instrumentation.
Communicate effectively with other team members and teams regarding the generated analytical data.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

Interaction with: Other team members and teams.
Nature of Interaction: Communicate effectively regarding the analytical data.

Type of Interaction: External :

Interaction with: Not explicitly specified in the vacancy details.
Nature of Interaction: Not explicitly specified in the vacancy details.

JOB REQUIREMENTS Professional Experience And Relevant Skills

Experience: 2-5 years of experience within an analytical development laboratory setting.
Skills: Hands-on experience in HPLC and UPLC is mandatory. Knowledge and hands-on experience of different chromatography modes like RP, HIC, IEX, SEC, etc., is required. Knowledge and hands-on experience of different capillary electrophoresis techniques (CIEF, CZE, CE-SDS, etc.) is required. Hands-on experience with Higher order structure analysis (DSC, CD, Fluorescence, FTIR, etc.) is an advantage.
Technical Expertise: Experience working on biotherapeutic proteins like monoclonal antibodies, Fc fusion, peptibody, or any candidate biosimilars is required. Method Development and Qualification experience is a must. An understanding of analytical deliverables involving CQA, QTPP, Analytical similarity, Forced degradation studies, and Specifications setting is preferred.

Academic Qualifications & Certifications

Educational Qualification: BSc./MSc. Biotechnology or B.Tech/Mtech. Biotechnology

BRL (Research Associate) - R&D - Analytical - 2