Syngene International Ltd. is a premier contract research organization and a subsidiary of Biocon Ltd. They are dedicated to delivering high-quality, integrated scientific services to their global partners across the pharmaceutical, biotechnology, and agrochemical industries. Syngene is renowned for its state-of-the-art facilities, commitment to innovation, and a strong culture of quality and compliance. Working at Syngene means being part of a team that is at the forefront of scientific discovery and manufacturing excellence.
Job Description: Analytical Scientist
The Analytical Scientist will be a key player in the organization’s laboratory operations, ensuring the highest standards of analytical chemistry and data integrity. The role demands a deep understanding of modern analytical techniques and strict adherence to global regulatory standards.
Key Responsibilities
- Perform routine and non-routine analysis of drug substances and products using various analytical techniques.
- Ensure proper instrument calibration and maintenance to guarantee accurate and reliable results.
- Develop, validate, and transfer analytical methods as per ICH and other regulatory guidelines.
- Conduct testing of stability samples and generate stability reports to support product shelf-life.
- Maintain comprehensive and accurate documentation in electronic notebooks as per GxP requirements.
- Prepare and review standard operating procedures (SOPs), protocols, and reports.
- Ensure all activities comply with cGMP regulatory requirements.
- Participate in internal and external audits, including readiness for inspections by agencies like the US FDA and MHRA.
Eligibility Criteria & Requirements
To be considered for this Analytical Scientist position at Syngene, candidates must meet the following requirements:
- Educational Qualification: M.Sc. (with 6-17 years of experience) or M.Pharm (with 5-15 years of experience).
- Technical Knowledge: Strong theoretical and practical background in analytical chemistry.
- Regulatory Expertise: Must have hands-on experience working in a cGMP-regulated environment.
- Method & Instrument Skills: Proven experience in method validation, instrument calibration, and routine analysis.
- ICH & GxP Knowledge: A solid understanding of ICH guidelines and documentation practices per GxP requirements.
- Software Proficiency: High proficiency in MS Office tools (Word, Excel, PowerPoint).
- Preferred Experience: Prior exposure to regulatory inspections such as US FDA or MHRA is a significant advantage.
How to Apply for the Analytical Scientist Position at Syngene
If you meet the above qualifications and are excited about this opportunity, follow these steps to apply:
- Prepare an updated copy of your CV or resume.
- Send your CV directly to: swetha.pawate@syngeneintl.com
