Scientist, BAL-II

About the Role

The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity.

Key Responsibilities

• Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, and regulatory guidance without deviation.
• Regular interaction and participation with Study Director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations, and archival.
• Involved in strategic planning for project execution, documentation of data, data analysis, and interpretation of results.
• Ensure completion of assigned tasks in a timely manner.
• Actively involved in discussions of SOPs, protocols, methods, and reports.
• Prepare reagents, buffers, and maintain logbooks for assigned assays.
• Interpret results, anticipate and understand issues related to the assay.
• Participate in and present data for discussions.
• Follow environment, health, and safety (EHS) requirements at all times, ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures.

Requirements & Tech Stack

• Hands-on experience in Ligand Binding Assay (LBA) development, validation, and sample analysis.
• Knowledge of ELISA and MSD assays is highly desirable.
• Knowledge and experience with regulatory requirements: OECD, GXP, 21 CFR Part 11, EMA, and FDA guidelines.

Qualifications

• Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field.

Behavioral Skills

• Should be independent.
• Excellent communication skills - written and oral in English.
• Good interpersonal skills.
• Flexibility and ability to work under strong time pressure.