Syngene Research Associate Pharmacokinetics & Immunogenicity Assays
Syngene Research Associate – Pharmacokinetics & Immunogenicity Assays. Syngene MSc Biological Science Job. Check the details on the positions available, the job description, the key responsibilities, work experience, functional experience all below:
Designation: Senior Research Associate – Pharmacokinetics and Immunogenicity Assays
Job Location: Bangalore
Job ID: 33402
Department: Immunogenicity Research Laboratory
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.
- Ensure to complete the assigned tasks in a timely manner.
- Prepare reagents, buffers and maintain a logbook 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.Experience: 1-3 years of total experience in Pharmacokinetics and Immunogenicity Assays.
Technical & Functional Skills:
- Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols.
- Should have 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 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.
Behavioural Skills:
- Should be independent.
- Excellent communication skills – written and oral in English
- Should have good interpersonal skills
- Large degree of flexibility and ability to work under strong time pressure
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