Clinical Supplies Specialist Job at Alvotech (R&D – Clinical Trials)
Job Summary
Position: Clinical Supplies Specialist
Organization: Alvotech
Division: Clinical & Medical Affairs (R&D – iCMR)
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full Time
Experience Needed: 2–5 Years
Application Closing Date: March 15, 2026
The Clinical Supplies Specialist will be responsible for managing the planning, procurement, packaging, labeling, distribution, and inventory control of supplies for biosimilar clinical trials.
Primary Duties
Clinical Supply Planning
- Create and update supply plans for biosimilar clinical trials
- Incorporate patient enrollment predictions, manufacturing schedules, and protocol needs
- Perform risk evaluations for potential supply limitations
Forecasting & Procurement
- Predict demand for comparator and reference products
- Assist in procuring Reference Listed Drugs (RLD) and additional supplies
- Coordinate supply strategies aligned with clinical trial schedules
Clinical Supply Operations
- Supervise packaging, labeling, and shipment of investigational medicinal products (IMP)
- Oversee cold chain logistics for biologics
- Organize and track IMP distribution and returns
Vendor & Budget Management
- Work with vendors for inventory updates and supply chain coordination
- Manage RFPs, SOWs, and vendor agreements
- Monitor vendor KPIs and service-level agreements
Compliance & Documentation
- Maintain clinical supply documentation in systems such as IRT, ERP, and eTMF
- Ensure compliance with ICH-GCP, GMP, FDA, EMA, and global regulatory standards
- Support regulatory inspections as a clinical supply subject matter expert
Cross-Functional Collaboration
- Coordinate with Clinical Operations, Clinical Science, Regulatory Affairs, and Project Management teams
- Develop supply forecasts based on patient enrollment and drug usage patterns
Qualifications
Education
Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
Experience
- 2–5 years of experience in clinical supply management
- Experience in biologics or biosimilar clinical trials preferred
Technical Skills
- Knowledge of GxP compliance (GMP/GCP)
- Understanding of cold chain logistics for biologics
- Experience with IRT systems and clinical supply forecasting tools
- Familiarity with clinical trial supply chain processes
Additional Skills
- Strong organizational and project management skills
- Ability to work in cross-functional global teams
- Understanding of biosimilar regulatory requirements
Salary & Benefits
₹10 LPA – ₹18 LPA (depending on experience)
- Hybrid / remote work flexibility
- Exposure to global clinical research programs
- Learning opportunities in biosimilar development
- Career growth in biopharmaceutical R&D
Application Process
Interested candidates can apply through the official company career portal before March 15, 2026.
