Job Description – R&D Manager (API & Intermediate)
Position: R&D Manager
Department: Research & Development
Location: Saykha, Bharuch, Gujarat
Industry: API & Pharmaceutical Intermediates Manufacturing
Employment Type: Full-Time
Job Summary
The R&D Manager will lead research and development activities for APIs (Active Pharmaceutical Ingredients) and Pharmaceutical Intermediates. The role involves process development, process optimization, technology transfer, scale-up activities, regulatory compliance, and team management to ensure successful commercialization of products.
Key ResponsibilitiesProcess Development & Optimization
- Develop and optimize manufacturing processes for APIs and Pharmaceutical Intermediates.
- Conduct laboratory and pilot-scale trials.
- Improve process yield, quality, and cost-effectiveness.
- Troubleshoot process-related issues and implement corrective actions.
Technology Transfer
- Lead technology transfer from R&D to Production.
- Support scale-up and commercial manufacturing activities.
- Prepare technology transfer documentation and reports.
Documentation & Compliance
- Prepare and review process development reports, SOPs, batch records, and technical documents.
- Ensure compliance with cGMP, ICH, and regulatory guidelines.
- Support regulatory submissions and customer requirements.
Project Management
- Plan and execute R&D projects within defined timelines.
- Coordinate with Production, QA, QC, Engineering, and Regulatory departments.
- Monitor project milestones and deliverables.
Team Leadership
- Lead and mentor the R&D team.
- Conduct technical training and performance reviews.
- Foster a culture of innovation and continuous improvement.
Audit & Regulatory Support
- Participate in internal, customer, and regulatory audits.
- Implement CAPA and continuous improvement initiatives.
- Ensure data integrity and laboratory compliance.
Qualification
- M.Sc. (Organic Chemistry) / M.Pharm / Ph.D. (Preferred)
Experience
- 10–15 Years of experience in API and Pharmaceutical Intermediates R&D.
- Experience in process development, scale-up, technology transfer, and commercialization.
Required Skills
- API Process Development
- Intermediate Process Development
- Technology Transfer & Scale-Up
- Regulatory Documentation
- Process Validation
- Root Cause Analysis
- Team Management
- cGMP Compliance
- MS Office (Excel, Word, PowerPoint)
Salary
CTC: Based on experience
Preferred Candidate Profile
- Strong expertise in API and Intermediate manufacturing processes.
- Experience in handling multiple R&D projects independently.
- Excellent leadership, analytical, and problem-solving skills.
- Exposure to regulatory audits and compliance requirement
Benefits:
Work Location: In person
