Company: Novartis
Novartis Official Website
Location: Hyderabad (Genome Valley / Office)
Employment Type: Full-time
Requisition ID: REQ-10076424
Application Deadline: May 26, 2026
1. Role Overview
The Senior Expert Drug Supply (Process Chemist) is responsible for managing early-phase small molecule drug substance development, from GLP toxicology batches through to first-in-human (FIH) supply.
The role focuses on process chemistry, GMP manufacturing oversight, and external partner (CDMO) management to ensure high-quality drug substance delivery for clinical development.
2. Core Responsibilities
A. Process Chemistry & Drug Substance Development
Manage early-phase chemical development projects (GLP tox to FIH supply)
Provide scientific guidance for small molecule drug substance scale-up
Support development of robust, scalable synthetic processes
B. External Manufacturing (CDMO) Management
Guide external manufacturing partners in planning and executing chemical production
Oversee GMP manufacturing activities including:
Master batch record (MBR) handling
Deviation management
Change control processes
Ensure compliance with regulatory and health authority expectations
C. Technical Oversight & Troubleshooting
Support daily operations at external manufacturing sites
Troubleshoot process and production issues in real time
Review technical and GMP-relevant documentation
Ensure timely delivery of drug substance materials
D. CMC & Regulatory Support
Contribute to CMC (Chemistry, Manufacturing & Controls) documentation
Support regulatory submission content related to drug substance
Ensure documentation aligns with global regulatory expectations
E. Cross-Functional & External Collaboration
Act as liaison between internal teams and external partners (CDMOs)
Participate in drug substance project team discussions (internal & external)
Contribute to strategic planning of chemical development projects
Evaluate and onboard new external manufacturing partners
F. Systems, Data & Process Development
Support development of databases and documentation workflows
Improve document flow and data management processes within EPM unit
Contribute to scientific exchange forums internally and externally
3. Required Qualifications
Education
PhD or Master’s (M.Sc.) in Synthetic Organic Chemistry
Experience
8–12 years of hands-on pharmaceutical industry experience
Strong background in:
Chemical development
GMP manufacturing (development and/or commercial scale)
Process scale-up from lab to plant
Experience in CDMO or external manufacturing environments preferred
Technical Knowledge
GMP manufacturing systems and documentation:
Tech transfer documents
Batch manufacturing records (BMR)
Deviation handling
CAPA systems
4. Core Skills
Scientific & Technical Skills
Process chemistry and scale-up
Drug substance manufacturing
GMP compliance and documentation
CMC regulatory support
Troubleshooting in manufacturing environments
Operational & Coordination Skills
External partner management (CDMO oversight)
Cross-site coordination (global + India operations)
Project execution and delivery accountability
Data/document workflow management
Behavioral Skills
Strong communication and coordination
High learning agility
Independent decision-making
Collaborative and solution-oriented mindset
5. Key Skill Areas (From JD Keywords)
Chemical Development & Process Chemistry
GMP Manufacturing & Compliance
CMC Documentation & Regulatory Support
Data Management (support systems & workflows)
External Partner (CDMO) Management
Pharmaceutical Scale-Up Operations
6. Organizational Context
This role sits within Global Drug Development (GDD) and Chemical & Analytical Development (CHAD), supporting early-phase clinical supply of small molecule drugs. It plays a critical role in bridging lab-scale chemistry and industrial manufacturing for clinical trial readiness.
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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Remote, India | Siliguri |Illinois :
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