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

- Solid 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 :

- Provident Fund

Work Location: In person

📌 R&d Manager (Ankleshwar)
🏢 Globela Pharma Unit-II
📍 Ankleshwar