ASSOCIATE EXPERT SCIENCE & TECHNOLOGY
Company: Novartis
Location: Genome Valley, Hyderabad, India
Job ID: REQ-10081362
Employment Type: Full Time
Department: Global Analytical R&D (Technical Research & Development)
JOB OVERVIEW
The Associate Expert Science & Technology is responsible for analytical method development, validation, transfer, stability testing, and release testing for innovative oligonucleotide and peptide therapeutics. The role focuses on advanced analytical characterization using chromatography and mass spectrometry techniques while ensuring compliance with GMP, GLP, and regulatory requirements.
KEY RESPONSIBILITIES
• Analytical Method Development
Perform analytical method feasibility studies.
Develop and validate robust analytical methods for oligonucleotide and peptide therapeutics.
Support analytical method optimization and troubleshooting.
Participate in analytical technology transfers.
• Chromatography & Mass Spectrometry
Utilize advanced liquid chromatography techniques including:
Reverse Phase (RP)
Ion Exchange Chromatography (IEX)
Hydrophilic Interaction Chromatography (HILIC)
Perform impurity profiling and characterization.
Apply mass spectrometry techniques for:
Mass confirmation
Sequencing
Quantitative impurity analysis
Interpret analytical data and generate scientific conclusions.
• Laboratory Operations
Plan and execute laboratory experiments according to timelines.
Conduct:
Method Development
Method Validation
Method Transfer
Stability Testing
Release Testing
Formulation Analytics
Ensure efficient laboratory workflow and resource management.
• Documentation & Compliance
Maintain Good Documentation Practices (GDP).
Follow Good Laboratory Practices (GLP).
Ensure GMP compliance throughout laboratory activities.
Record and submit raw data into LIMS systems.
Maintain complete and accurate analytical records.
• Data Analysis & Investigation
Evaluate and interpret analytical results.
Investigate:
SST Failures
OOX (Out of Expectation) Results
Deviations
Change Controls
Support root cause analysis and CAPA implementation.
• Laboratory Management
Manage assigned laboratory resources:
Chemicals
Reagents
Consumables
Columns
Glassware
Samples
Support lean laboratory initiatives.
Promote sustainable laboratory practices.
• Quality & Audit Support
Achieve Key Quality Indicators (KQIs).
Meet Key Performance Indicators (KPIs).
Support internal and external audits.
Ensure inspection readiness and compliance.
• Stakeholder Communication
Communicate critical issues proactively.
Collaborate with project teams and managers.
Prepare scientific reports and presentations.
Support cross-functional project discussions.
EDUCATION
M.Pharm
M.Sc (Analytical Chemistry, Pharmaceutical Chemistry, Biotechnology, Life Sciences, or related fields)
EXPERIENCE
2–5 Years
Pharmaceutical Industry Experience
Analytical Development Experience
Oligonucleotide Analytics Experience
Peptide Analytics Experience
GMP Environment Experience
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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