About this role
Job Purpose: 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, regulatory guidance without deviating from established procedures.
- 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.
- Will be involved in strategic planning for project execution, documentation of data, data analysis and interpretation of the results Ensure to complete the assigned tasks in timely manner.
- Actively involved in discussion of SOPs, protocols, method and reports Prepare reagents, buffers and maintain log book for assigned assays Interpret results – anticipate and understand the issues related to the assay.
- Participate in, and present data for discussions.
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
- Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field.
- Technical/functional Skills: Background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols is highly preferable.
- Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis.
- Knowledge of ELISA and MSD assays are highly desirable.
- Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines.
- Experience: 5-8 years of total experience in Pharmacokinetics and Immunogenicity Assays Behavioral Skills: Should be independent Excellent communication skills - written and oral in English Should have good interpersonal skills Flexibility and ability to work under strong time pressure