Research Associate
4 weeks ago
Job Title: Research Associate - Pharmacokinetics and Immunogenicity Assays
About the Role:
The successful candidate will be responsible for performing bioanalysis, including ligand binding assays related to Pharmacokinetics and Immunogenicity. This role requires a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays, with a good understanding of regulatory guidance and industry practices.
Key Responsibilities:
- Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, and regulatory guidance.
- 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 assigned tasks in a timely manner.
- Prepare reagents, buffers, and maintain log books 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 in the workplace, ensuring individual and lab/plant safety.
- Attend training on environment, health, and safety (EHS) measures imparted by the company.
Requirements:
- Master's degree in Biological Sciences (preferably Biochemistry background) or a related field.
- Strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays.
- 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, such as Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA), and Food and Drug Administration (FDA) guidelines.
- 0-3 years of total experience in Pharmacokinetics and Immunogenicity Assays.
What We Offer:
Syngene is an equal opportunity employer and provides a competitive salary and benefits package to its employees.
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