Assistant Manager - R&D

Quality HR India Pvt. Ltd.; Vapi; On-site; INR 990,000 - 1,210,000; Full time

Job summary

Quality HR India Pvt. Ltd. in Vapi invites an experienced Asst. Manager - R&D to lead API research and development activities. You will develop manufacturing processes, scout routes, optimize processes, and supervise lab scale-up while ensuring GMP/GLP compliance and thorough documentation.

The role requires 8–10 years in pharma API R&D, a B.Pharm/M.Pharm/B.Sc/M.Sc in chemistry, and a track record in process optimization, impurity profiling and technology transfer to production.

Qualifications

• Experience in API R&D and process development for pharma APIs.
• Proficiency in organic synthesis, route scouting and scale-up.
• Knowledge of GMP/GLP/ICH guidelines and regulatory requirements.
• Experience with impurity profiling and analytical method development.

Responsibilities

• Lead API R&D activities including new product development.
• Develop and optimize API manufacturing processes and routes.
• Conduct trials, experiments and scale-up activities.
• Drive process improvement, yield enhancement and cost reduction.
• Oversee impurity profiling, characterization and validation.
• Coordinate tech transfer with QC/QA/Production.
• Prepare technical documents, SOPs and development protocols.
• Ensure GMP/GLP/ICH compliance and regulatory adherence.
• Guide R&D team and monitor project progress.
• Troubleshoot process issues and support plant trials.

Skills

API Research & Development

Process Development

Organic Synthesis

Route Scouting

Process Optimization

Synthetic Chemistry

Impurity Profiling

Analytical Method Development

Scale-up and Technology Transfer

Process Validation

Reaction Monitoring

HPLC / GC

GMP / GLP / ICH Guidelines

DMF Documentation

Team Management

Cost Optimization

Education

B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Job description

Position: Asst. Manager - R&D

Location: Vapi

Experience: 8- 10 Years

Industries: Pharma -API

Responsibilities

• Lead and manage API Research & Development activities, including new product development.
• Develop and optimize API manufacturing processes and synthetic routes.
• Handle process development, route scouting and process optimization.
• Conduct laboratory trials, experiments and scale-up activities.
• Work on process improvement, yield enhancement and cost reduction.
• Handle impurity profiling, characterization and process validation.
• Coordinate with QC, QA and Production teams for technology transfer.
• Prepare and review technical documents, reports, SOPs and development protocols.
• Ensure compliance with GMP, GLP, ICH guidelines and regulatory requirements.
• Guide and supervise R&D team members and monitor project progress.
• Troubleshoot process-related issues and provide technical solutions.
• Support plant trials and commercial manufacturing activities.

Required Skills

• API Research & Development
• Process Development
• Organic Synthesis
• Route Scouting
• Process Optimization
• Synthetic Chemistry
• Impurity Profiling
• Analytical Method Development
• Scale-up and Technology Transfer
• Process Validation
• Reaction Monitoring
• HPLC / GC
• GMP / GLP / ICH Guidelines
• DMF Documentation
• Team Management
• Cost Optimization

Required Qualification:- B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Salary :- Upto 11.00 LPA