Position: Executive / Officer – Research & Development (R&D) – API Pharmaceuticals
Department: Research & Development (R&D)
Location: Manufacturing / R&D Facility
Reporting To: Manager / Head – R&D
Job Summary
Responsible for development, optimization, scale-up, and technology transfer of API manufacturing processes. The role involves conducting laboratory experiments, process improvements, documentation, and supporting commercial production while ensuring compliance with quality, safety, and regulatory requirements.
Key Responsibilities
- Conduct laboratory experiments for process development and optimization of APIs and intermediates.
- Perform route scouting, process evaluation, and feasibility studies for new products.
- Develop cost-effective, scalable, and robust manufacturing processes.
- Prepare and execute experimental protocols and maintain laboratory notebooks.
- Analyze experimental data and prepare technical reports.
- Support process scale-up from laboratory to pilot plant and commercial production.
- Participate in technology transfer activities and provide technical support to Production.
- Identify and resolve process-related issues during development and manufacturing.
- Prepare development reports, process descriptions, SOPs, risk assessments, and technical documents.
- Coordinate with ARD, QA, QC, Production, Engineering, and Regulatory Affairs teams.
- Ensure compliance with cGMP, GLP, EHS, and regulatory requirements.
- Participate in process validation, cleaning validation, and continuous improvement projects.
- Support patent evaluation and literature searches for new process development.
Qualification
- M.Sc. (Organic Chemistry) / M.Sc. (Chemistry) / M.Pharm / B.Tech Chemical Engineering or equivalent.
Experience
- Officer: 1–3 years of experience in API R&D.
- Executive: 3–6 years of experience in API process development, scale-up, and technology transfer.
Required Skills
- Strong knowledge of organic synthesis and API manufacturing processes.
- Hands-on experience in laboratory reactions, purification techniques, and process optimization.
- Understanding of process chemistry, reaction mechanisms, and impurity profiling.
- Knowledge of cGMP, GLP, and regulatory requirements.
- Experience in technology transfer and scale-up activities.
- Good documentation and technical report-writing skills.
- Proficiency in MS Office applications.
- Strong analytical, troubleshooting, and problem-solving abilities.
Preferred Experience
- Exposure to regulated markets such as USFDA, EU-GMP, WHO-GMP, and other international regulatory requirements.
- Experience in handling pilot plant and commercial scale-up activities.
- Knowledge of process safety assessments and risk management.
Key Competencies
- Process Development Expertise
- Technical Problem Solving
- Innovation and Continuous Improvement
- Documentation and Compliance
- Team Collaboration
- Project Management
Salary: As per company norms and experience.
Shift: General Shift.
Industry: API Pharmaceuticals.
Experience Range: 1–6 Years.
Pay: ₹25,000.00 - ₹30,000.00 per month
Work Location: In person
