Senior Scientist – Analytical Chemistry
Location: Bangalore, Karnataka, India
Company: Syngene International
Department: Analytical Chemistry / Quality Control / Biologics
Employment Type: Full-Time
Role Summary
The Senior Scientist – Analytical Chemistry is responsible for analytical method development, method validation, stability testing, instrument qualification, and quality control activities for drug substances and drug products within a GMP-regulated environment. The role focuses on ensuring analytical compliance, data integrity, regulatory readiness, and high-quality laboratory operations while supporting pharmaceutical and biologics development programs.
The position requires strong expertise in chromatographic techniques, laboratory documentation practices, quality management systems (QMS), and analytical testing of pharmaceutical products. Experience with biologics, monoclonal antibodies (mAbs), complex injectables, SEC, and CGE methods is highly desirable.
Key Responsibilities
Analytical Method Development & Validation
Develop and validate:
Assay Methods
Related Substances Methods
Stability-Indicating Methods
Drug Substance Analytical Methods
Drug Product Analytical Methods
Perform analytical troubleshooting and method optimization.
Support analytical lifecycle management activities.
Analytical Testing
Conduct:
Stability Studies
Release Testing
Method Transfer Activities
Investigational Testing
Analyze and interpret analytical data.
Ensure data integrity and regulatory compliance.
Instrument Operation & Maintenance
Operate and maintain:
HPLC
UPLC/UHPLC
GC
UV-Visible Spectrophotometer
Potentiometer
Stability Chambers
Use Empower-3 Software for chromatographic data analysis.
Perform calibration and qualification of laboratory instruments.
Biologics & Advanced Analytical Techniques
Develop and validate:
SEC (Size Exclusion Chromatography) Methods
CGE (Capillary Gel Electrophoresis) Methods
Support analytical characterization of:
Monoclonal Antibodies (mAbs)
Complex Injectable Products
Perform:
Particle Size Analysis
Zeta Potential Analysis
Particulate Matter Analysis
Quality Management & Compliance
Ensure compliance with:
GMP
GxP
ALCOA+ Principles
Internal SOPs
Manage:
Deviations
OOS (Out of Specification) Investigations
Change Controls
Incidents
Support audit and inspection readiness activities.
Documentation & SOP Management
Prepare and review:
Raw Data Sheets
SOPs
Instrument Operating Procedures
Analytical Reports
Maintain accurate laboratory documentation and records.
Inventory & Laboratory Management
Manage procurement and inventory of:
Pharmacopeial Standards
Chemicals
Reagents
Consumables
Laboratory Spares
Ensure uninterrupted laboratory operations.
Stakeholder Communication
Communicate with:
Internal Teams
Global Clients
External Stakeholders
Prepare technical reports and scientific updates.
Participate in client discussions and project reviews.
Required Qualifications
Education
Required:
M.Pharm
M.Sc (Analytical Chemistry, Pharmaceutical Chemistry, Chemistry, Life Sciences)
Experience
Experience in:
Analytical Method Development
Method Validation
GMP Analytical Laboratories
Pharmaceutical QC/Analytical R&D
Entry-level lateral candidates with relevant analytical experience may be considered.
Uttar Pradesh :
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