Scientist - Analytical

Syngene International Limited; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Syngene International Limited in Bengaluru invites applications for a role focused on method development and validation using LCMS/GCMS. The candidate will perform Extractables/Leachables studies and support regulatory compliance and documentation.

The work includes drafting SOPs, training, and ensuring 21 CFR Part 11 and data integrity practices where applicable in a CGMP environment. Prior experience in troubleshooting instruments is preferred.

Qualifications

• Experience with LCMS/GCMS method development and validation.
• Knowledge of CGMP, ICH, USP and data integrity requirements.
• Familiar with GMP practices and instrument qualification, calibration, and troubleshooting.

Responsibilities

• To perform method development and validation studies using LCMS or GCMS.
• To conduct Extractables/Leachables, Nitrosamines studies using LCMS or GCMS.
• Responsible for preparation of test procedures, development reports, validation protocols and reports.

Job description

Date: 7 Aug 2026

Location:

Bangalore, KA, IN, 560099

Division: Dedicated Centre

• To perform method development and validation studies using LCMS or GCMS techniques.
• To be able to conduct Extractables/Leachables, Nitrosamines studies using LCMS or GCMS.
• Responsible for preparation of test procedures, development reports, technical reports, validation protocols and reports.Abilities in qualification, calibration and troubleshooting of analytical instruments.
• To carry out the investigations in case of deviations, OOT, OOC & OOS.To ensure instruments are compliant to 21 CFR Part 11 requirements, wherever applicable.
• Preparation & review of SOPs, IOPs and EOPs and provide training whenever required.
• Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.Must comply with GMP, data integrity & EHSS practices.