Sun Pharma is India’s largest pharmaceutical company and a leading global specialty generic player. With a strong presence in over 100 countries, Sun Pharma is known for its innovation in complex generics, specialty drugs, and novel drug delivery systems. The company invests heavily in R&D, focusing on developing high-quality, affordable medicines for patients worldwide.
Job Description
Sun Pharma is looking for an experienced Executive – Formulation R&D (Injectable Products) to join its Tandalja R&D team. The role involves working on Novel Drug Delivery Systems (NDDS), Lyophilized Products, and Solution Formulations while ensuring compliance with regulatory guidelines.
Key Responsibilities:
✔ Conduct literature search and understand Regulatory (USFDA/EMA) guidelines for injectable product development.
✔ Procure raw materials (API/excipients), packaging materials, and reference products in coordination with purchase departments.
✔ Prepare testing/analysis license applications for new products.
✔ Design and execute pre-formulation & formulation development studies using QbD (Quality by Design) approach.
✔ Maintain Lab Notebooks with detailed experimental records.
✔ Prepare TR/IOM (Test Request/Investigation of Materials) for API/excipient analysis.
✔ Develop stability study protocols, reports, and SOPs for lab instruments.
✔ Support Technology Transfer activities (Sheet II, Master Formula, Risk Assessment, FMEA, SDS).
✔ Coordinate with cross-functional teams for scale-up, exhibit batches, and commercial production.
✔ Compile Product Development Reports (PDR), Risk Assessment Reports, and project documentation.
✔ Ensure compliance with internal quality systems and regulatory audit requirements.
Qualifications & Experience
✅ Education: M.Pharm / B.Pharm / MS in Pharmaceutical Sciences / MSc / Ph.D
✅ Experience: 2-5 years in Injectable Product Development (Lyophilized/Solution/NDDS)
✅ Skills Required:
- Strong knowledge of Regulatory Guidelines (USFDA/ICH/EMA)
- Hands-on experience in QbD, DoE (Design of Experiments), and FMEA
- Proficiency in Lyophilization, Sterile Product Development, and Analytical Testing
- Excellent documentation and technical writing skills
Why Join Sun Pharma?
🌍 Global Leader in Pharmaceuticals with a strong R&D focus
💼 Career Growth in a fast-paced, innovation-driven environment
🔬 Cutting-edge Research in Novel Drug Delivery Systems
🏆 Employee Benefits including health insurance, bonuses, and learning opportunities
