Expert Science & Technology – Analytical Research & Development (ARD)
Job ID: REQ-10065366
Location: India (Hyderabad)
Posted on: November 04, 2025
Job Type: Full-Time | Regular
Functional Area: Research & Development
Job Summary
The Expert Science & Technology professional will lead the design, execution, interpretation and reporting of analytical results to support the development and timely delivery of drug substances (DS), drug products (DP), and associated processes within Global Analytical Research & Development (ARD). This role requires strong expertise in analytical method development, method validation, regulatory and strategic understanding, and operational excellence across laboratory and plant environments.
You will support the full analytical portfolio aligned with GDD, NTO and NIBR programs, ensuring compliance, technical accuracy and scientific rigor across all assigned projects.
Key Responsibilities
Analytical & Technical Leadership
Provide analytical and technical support to PHAD and project teams across key development stages including CSF, FMI and LCM.
Design, develop and author analytical method documents, stability protocols, APS/EC reports and related technical documentation.
Support analytical development strategy in collaboration with the Analytical Project Leader.
Interpret analytical data, compile findings and present insights, observations and proposed solutions to key stakeholders.
Project & Operational Management
Manage all project-related sample handling including sampling plans, storage, distribution and reconciliation.
Plan and coordinate analytical activities to ensure adherence to project timelines, KPIs and KQIs.
Oversee laboratory and third-party testing logistics to maintain operational alignment.
Serve as the single point of contact for PHAD, cross-functional teams and external partners on project execution.
Ensure equipment qualification, maintenance and laboratory infrastructure readiness.
Compliance & Quality Assurance
Support internal and external audits and ensure zero critical findings in assigned projects.
Work strictly in accordance with GMP, GLP, SOPs, QM, HSE, ISEC and all Novartis operational guidelines.
Demonstrate proactive risk identification and communicate critical issues promptly to leadership.
Documentation & Governance
Author EC/APS protocols and reports, review test methods and compatibility study plans.
Access, review and maintain relevant SOPs as per ESOPS requirements.
Required Experience
Education & Industry Experience
M.Sc / M.Pharm with 6–9 years of experience in the pharmaceutical industry.
Ph.D. with 2–3 years of relevant industry experience.
Technical Skills
Strong expertise in analytical method development and validation for assays, impurities, dissolution and content uniformity (OSD and parenteral formulations).
In-depth understanding of ICH guidelines, regulatory expectations, Analytical Target Profile (ATP) and lifecycle management of analytical procedures.
Hands-on experience in:
HPLC and UPLC (Empower, Chromeleon)
UV-Vis spectroscopy
DVS systems
Dissolution testing systems
Proficiency in liquid chromatography best practices and method robustness.
Strong troubleshooting and routine maintenance capabilities for analytical instruments.
Language Requirement
Proficiency in English (verbal and written).
Why Join Novartis
At Novartis, we believe that transforming patients’ lives requires more than scientific innovation. It requires a global community of talented and driven professionals working collaboratively to deliver meaningful breakthroughs. Join us to shape the future of healthcare and contribute to solutions that improve patient outcomes worldwide.
Location & Organizational Details
Division: Development
Business Unit: Development
Site: Hyderabad (Office)
Company: Novartis Healthcare Private Limited
Shift Work: No
Accessibility & Accommodation
Novartis is committed to providing reasonable accommodation for individuals with disabilities. If you require assistance during the recruitment process or to perform essential job functions, please email: diversityandincl.india@novartis.com, including the job requisition number and your contact details.
Novartis strives to foster an inclusive work culture and build diverse teams that represent the communities and patients we serve.
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