Syngene International Ltd. is a leading integrated research, development, and manufacturing services organization, working with some of the biggest names in the pharmaceutical, biotechnology, and nutrition industries. With over 4,500 scientists and cutting-edge research facilities, Syngene offers solutions from discovery to manufacturing, catering to global giants such as Amgen, Baxter, Bristol-Myers Squibb, GSK, and Merck KGaA. Syngene’s commitment to speed, quality, and innovation has earned it a reputation as a trusted partner in delivering scientific excellence and robust data management.
The company focuses on advancing cutting-edge science and supporting its partners in reducing time-to-market and lowering the cost of innovation. It also emphasizes compliance, intellectual property security, and sustainable manufacturing practices.
Responsibilities in the Job
As a Research Associate in Pharmacokinetics and Immunogenicity Assays, the candidate will work within Syngene’s Immunogenicity Research Laboratory. The key responsibilities include:
- Conduct bioanalysis using ligand binding assays (LBA) to assess pharmacokinetics and immunogenicity.
- Ensure lab activities comply with established Standard Operating Procedures (SOPs) and regulatory guidelines.
- Collaborate with Study Directors, Quality Control (QC), and Quality Assurance (QA) to review raw data and close observations efficiently.
- Maintain proper documentation, including logbooks, assay results, and reagent preparation records.
- Troubleshoot issues related to assays and interpret results effectively.
- Present data for discussions with stakeholders and actively participate in study meetings.
- Adhere to Environmental, Health, and Safety (EHS) requirements to ensure a safe working environment.
Educational Qualification
- Master’s degree in Biological Sciences, preferably with a background in Biochemistry or related fields.
- Candidates with 0-3 years of relevant experience in pharmacokinetics and immunogenicity assays are eligible to apply.
Technical and Functional Skills
- Hands-on experience in Ligand Binding Assay (LBA) development, validation, and sample analysis.
- Knowledge of ELISA and Meso Scale Discovery (MSD) assays is highly desirable.
- Familiarity with regulatory guidelines from authorities like the FDA, EMA, and OECD.
- Understanding of GXP standards and compliance with 21 CFR Part 11 protocols.
Behavioral Skills
- Ability to work independently with minimal supervision.
- Strong communication skills (both oral and written) in English.
- Good interpersonal skills and ability to work under time pressure.
- Flexibility and adaptability in handling multiple tasks and priorities.
