Assistant Manager - R&D

JobItUs; Vapi; On-site; INR 990,000 - 1,210,000; Full time

Job summary

JobItUs in Vapi, Gujarat is seeking an Asst. Manager - R&D with 8-10 years of pharma API experience. Lead API R&D activities, develop and optimize manufacturing processes, and supervise the R&D team to deliver scale-up and tech transfer.

You will work on impurity profiling, route scouting, and analytical method development, ensuring GMP/GLP/ICH compliance. A strong background in organic synthesis and DMF documentation is essential.

Qualifications

• 8–10 years in pharma API R&D or related fields.
• Proven experience in process development, scale-up and tech transfer.
• Strong background in organic synthesis and impurity profiling.
• Experience with GMP/GLP/ICH guidelines and regulatory documentation.

Responsibilities

• Lead API R&D activities including new product development.
• Develop and optimize API manufacturing processes and routes.
• Conduct trials, scale-up and process validation.
• Collaborate with QC/QA/Production for tech transfer.
• Prepare technical documents, SOPs and development protocols.
• Ensure GMP/GLP compliance and regulatory adherence.
• Guide R&D team and monitor project progress.
• Troubleshoot process issues and support plant trials.

Skills

API R&D

Process Development

Organic Synthesis

Route Scouting

Process Optimization

Synthetic Chemistry

Impurity Profiling

Analytical Method Development

Scale-up

Technology Transfer

Process Validation

Reaction Monitoring

HPLC

GMP/GLP/ICH

DMF Documentation

Team Management

Cost Optimization

Education

B.Pharm

M.Pharm

B.Sc (Chemistry)

M.Sc (Chemistry)

Tools

HPLC

GC

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