Expert Science & Technology – Analytical Research & Development (ARD)
Job ID: REQ-10065366
Location: Hyderabad, India
Posted On: November 04, 2025
Job Type: Full-Time | Regular
Functional Area: Research & Development
Position Overview
The Expert Science & Technology professional will play a critical role within Global Analytical Research & Development (ARD), overseeing the design, execution, interpretation and reporting of analytical experiments supporting drug substances (DS), drug products (DP), processes and procedures. This role requires strong scientific expertise in analytical method development, method validation, and a deep technical and strategic understanding of laboratory operations.
You will ensure timely support across the global portfolio in alignment with GDD, NTO and NIBR objectives while maintaining compliance, quality and operational excellence in laboratory and plant environments.
Key Responsibilities
Analytical & Scientific Operations
Design, plan and perform analytical experiments aligned with TRD vision and development timelines.
Provide analytical and technical support to PHAD and project teams across all stages of product development, including CSF, FMI and LCM.
Develop and author analytical documents such as analytical methods, stability protocols/reports, excipient compatibility studies and APS documentation.
Support the Analytical Project Leader in defining analytical development strategies.
Interpret experimental data, consolidate results and present critical insights and recommendations to project teams.
Project Management & Coordination
Manage end-to-end sample handling: sampling plans, issuance, storage, distribution and reconciliation.
Plan and supervise assigned project activities while ensuring adherence to KPIs and KQIs.
Coordinate laboratory requests, allocate tasks and manage logistics with external testing laboratories and third-party partners.
Serve as the primary point of contact for PHAD, cross-functional teams and stakeholders for project execution activities.
Proactively identify, communicate and escalate critical issues to relevant management levels.
Quality, Compliance & Documentation
Ensure readiness for internal and external audits while maintaining zero critical findings for assigned projects.
Execute responsibilities in strict alignment with GMP, GLP, SOPs, QM, HSE, ISEC and Novartis guidelines.
Author EC/APS protocols and reports; review test methods and compatibility study plans.
Ensure proper understanding and access to ESOPS relevant to assigned activities.
Required Experience & Qualifications
Educational Background
M.Sc / M.Pharm with 6–9 years of relevant industry experience
Ph.D. with 2–3 years of industry experience
Technical Skills & Expertise
Strong proficiency in developing and validating analytical methods for assays, impurities, dissolution and content uniformity for OSD and parenteral formulations.
Working knowledge of ICH guidelines, regulatory expectations, Analytical Target Profile (ATP), GLP and ALCOA+ principles.
Hands-on experience with:
HPLC and UPLC systems (Empower, Chromeleon)
UV-Vis spectroscopy
DVS systems
Dissolution testing platforms
Strong competence in LC chromatography, sample preparation and method reproducibility.
Ability to troubleshoot, calibrate and maintain analytical instruments.
Language Requirement
Proficiency in English.
Why Join Novartis
Novartis is driven by a commitment to advance science and improve patient outcomes worldwide. You will join a collaborative, diverse and innovative environment focused on developing groundbreaking solutions that transform lives. Explore people and culture insights at the Novartis website.
Company & Location Details
Division: Development
Business Unit: Development
Site: Hyderabad (Office)
Organization: Novartis Healthcare Private Limited
Shift Work: No
Accessibility & Accommodation
Novartis is dedicated to providing reasonable accommodation for candidates with disabilities. Applicants requiring support during the recruitment process or in performing essential job functions may contact:
Email: diversityandincl.india@novartis.com
Please include the job requisition number and your contact details.
Novartis is committed to building an inclusive workplace and fostering diverse teams that reflect the patients and communities served globally.
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