Expert Science & Technology (Analytical Development – Oligonucleotides & Peptides)
Job ID: REQ-10076531
Date: May 11, 2026
Location: Genome Valley, Hyderabad, India
Company: Novartis Healthcare Private Limited
Division: Technical Research & Development (TRD), Development
Job Overview
This role focuses on analytical method development and validation for innovative oligonucleotide and peptide therapeutics. It bridges analytical science with clinical performance to support the transformation of molecules into medicines that improve patient outcomes.
The position involves hands-on laboratory work, method development, regulatory compliance, and scientific documentation within a GMP-regulated environment.
Key Responsibilities
A. Analytical Method Development & Validation
Perform method feasibility studies and validate robust analytical methods
Work on advanced therapeutic modalities including:
Oligonucleotides
Peptides
Apply chromatography and mass spectrometry techniques for biological molecules
Support method transfer, stability testing, and release testing activities
B. Laboratory Execution & Scientific Studies
Plan, organize, execute, and document scientific experiments
Conduct analytical development studies in line with timelines and quality standards
Ensure compliance with GLP/GMP standards during laboratory operations
Maintain accurate experimental records and raw data documentation
C. Data Management & Reporting
Record and manage data in systems such as LIMS
Perform test activation and results entry
Ensure proper data integrity and good documentation practices (GDP)
Interpret experimental results and support scientific reporting
D. Investigation & Problem Solving
Investigate:
System suitability test (SST) failures
Out-of-specification (OOS/OOT) results
Deviations and change controls
Support root cause analysis and corrective actions
Collaborate with project teams to resolve technical issues
E. Laboratory Operations & Compliance
Manage laboratory resources (reagents, samples, columns, consumables, glassware)
Ensure efficient and sustainable lab practices
Support internal and external audits
Maintain compliance with regulatory and quality standards
Meet Key Quality Indicators (KQI) and Key Performance Indicators (KPI)
F. Communication & Collaboration
Communicate technical issues promptly to managers and stakeholders
Collaborate with cross-functional project teams
Contribute to scientific discussions and decision-making
Prepare scientific and technical presentations
Minimum Requirements
Education & Experience
PhD in Analytical Chemistry or related field with 1–3 years experience
OR
M.Pharm / M.Sc. with 8+ years experience in pharmaceutical analytical development
Technical Expertise
Strong experience in oligonucleotide and/or peptide analytics
Expertise in chromatography techniques:
Reverse Phase (RP)
Ion Exchange (IEX)
Hydrophilic Interaction Liquid Chromatography (HILIC)
Experience with mass spectrometry (preferred), including:
Mass confirmation
Impurity profiling
Sequencing applications
Regulatory & Compliance
Strong understanding of GMP requirements (mandatory)
Knowledge of regulatory and quality standards in pharma development
Core Skills
Scientific data interpretation and problem-solving
Strong documentation and technical writing skills
Laboratory execution and experimental design
Effective communication and presentation skills
Proficiency in tools:
Microsoft Office
LIMS systems
Chromatography software (e.g., Chromeleon)
Core Competencies
Analytical method development and validation
Chromatography and mass spectrometry expertise
GMP/GLP compliance
Scientific investigation and troubleshooting
Data integrity and regulatory documentation
Cross-functional collaboration
Work Environment
GMP-regulated pharmaceutical R&D environment
Focus on advanced therapeutic modalities (oligonucleotides & peptides)
Highly technical, laboratory-driven role
Strong emphasis on quality systems, compliance, and innovation
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