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Novartis is hiring an Expert Science & Technology professional for its Analytical Research & Development (ARD) division in Hyderabad. This full-time opportunity is ideal for experienced M.Pharm, MSc, or PhD professionals with strong expertise in analytical method development, validation, and lifecycle management for drug substances (DS) and drug products (DP).
This role plays a critical part in global pharmaceutical development by supporting product design, regulatory compliance, and analytical strategy execution, in alignment with Novartis’ TRD, GDD, NTO, and NIBR objectives.
Key Responsibilities
- Provide analytical and technical support to PHAD and cross-functional project teams across product development stages (CSF, FMI, LCM)
- Design, author, and review analytical methods, stability protocols/reports, excipient compatibility (EC) and APS documents
- Support analytical development strategy and lifecycle management aligned with ICH guidelines
- Perform data interpretation, result compilation, and present critical observations with scientific justification
- Manage project-related sample handling, including storage, issuance, reconciliation, and destruction
- Coordinate analytical activities with internal teams and external testing laboratories
- Act as single point of contact for project execution and stakeholder communication
- Ensure compliance with GMP, GLP, ALCOA+, SOPs, HSE, and Novartis Quality Systems
- Support internal and external audits with zero critical findings
- Maintain and troubleshoot analytical instruments and laboratory infrastructure
Eligibility & Qualifications
Educational Requirements
- M.Pharm / MSc with 6–9 years of pharmaceutical industry experience
OR - PhD with 2–3 years of relevant industry experience
Technical Skills Required
- Analytical method development & validation for:
- Assay, impurities, dissolution, content uniformity
- Oral solid dosage (OSD) and parenteral formulations
- Strong knowledge of ICH Q2, ATP, method lifecycle management
- Hands-on experience with:
- HPLC, UPLC (Empower, Chromeleon)
- UV-Vis spectroscopy, DVS, dissolution systems
- Instrument troubleshooting and maintenance expertise
- Knowledge of GLP, GMP, ALCOA+ principles
- Strong technical writing and documentation skills
Language
- English (Professional proficiency)
Preferred / Desired Skills
- Experimental design & data integrity
- Laboratory safety & EHS compliance
- SOP authoring and review (ESOPS, Subway systems)
- Materials science & manufacturing process understanding
- Cross-functional collaboration and project management
Salary & Benefits
- Estimated Salary: ₹15,00,000 – ₹25,00,000 per annum (INR)
- Competitive Novartis compensation structure
- Exposure to global drug development programs
- Career growth within a world-leading pharmaceutical innovator
- Strong focus on quality, innovation, and employee well-being
Job Location
📍 Hyderabad, Telangana (Office-based)
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How to Apply
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