Job Title
Principal Scientist – Analytical Chemistry
Company
Syngene International Ltd.
Location
Bangalore, Karnataka, India – 560099
Division / Department
Dedicated Centre – Analytical (BGRC)
Job Role Type
Principal Scientist (Analytical Chemistry)
Job Posting Date
26 May 2026
About the Company
Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization providing integrated scientific services across the drug discovery, development, and manufacturing lifecycle. The company operates with a strong focus on safety, quality, and regulatory compliance, serving global pharmaceutical and biotech clients.
Core Purpose of the Role
The role focuses on advanced analytical chemistry work, including method development, validation, transfer, and stability studies using instruments such as LC-MS and GC-MS. It also involves specialized analytical testing such as nitrosamines analysis and extractables & leachables studies.
Key Responsibilities
Perform method development and validation using LC-MS and GC-MS techniques
Conduct analytical studies including:
Extractables & Leachables (E&L)
Nitrosamines analysis
Prepare test procedures, validation protocols, and technical reports
Perform method transfer activities and R&D stability studies
Handle qualification, calibration, and troubleshooting of analytical instruments
Investigate deviations, OOT (Out of Trend), OOC (Out of Control), and OOS (Out of Specification) results
Ensure compliance with 21 CFR Part 11 where applicable
Develop, review, and maintain SOPs, IOPs, and EOPs
Provide training support when required
Ensure compliance with GMP, GLP, data integrity (ALCOA+), and EHS standards
Support regulatory compliance aligned with ICH and USP guidelines
Mandatory Safety & Compliance Expectations
Strict adherence to EHS (Environment, Health & Safety) guidelines
Promote a safety-first culture within teams
Ensure completion of mandatory safety and data integrity training
Maintain compliance with quality systems and operational discipline
Contribute to improving safety procedures and lab practices
Monitor and review safety performance metrics
Required Skills & Capabilities
Hands-on experience with:
LC-MS (Liquid Chromatography–Mass Spectrometry)
GC-MS (Gas Chromatography–Mass Spectrometry)
Strong understanding of:
Chromatography principles
Spectroscopy techniques
Experience in analytical method development and validation
Knowledge of regulatory guidelines (ICH, USP, GMP)
Strong documentation practices (ALCOA+)
Ability to perform lab work under guidance and SOPs
Proficiency in MS Office tools (Word, Excel, PowerPoint)
Behavioral Skills
Strong interpersonal and communication skills
Good time management and organizational ability
Ability to work effectively in a team environment
Attention to detail and compliance-oriented mindset
Experience Requirement
Strong experience working in an analytical laboratory (senior-level expertise expected)
Educational Qualification
M.Sc. / M.Tech / M.Pharm in Analytical Chemistry, Chemistry, or related field
Company Values
Employees are expected to demonstrate:
Excellence
Integrity
Professionalism
Equal Opportunity Statement
Syngene provides equal employment opportunities regardless of gender, race, disability, religion, nationality, or other protected characteristics and ensures reasonable accommodations for qualified individuals.
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