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