Scientist

Keka Technologies Private Limited; Sanand; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Keka Technologies Private Limited is seeking an API R&D Executive / Research Scientist with 3–4 years of experience to develop and optimize synthetic routes for APIs. The role involves laboratory experimentation, documentation, and supporting transfer to pilot plant and manufacturing...

The candidate should have strong organic chemistry expertise, hands-on lab experience, and familiarity with regulatory guidelines (GMP/GLP/ICH). Collaboration with QA, QC and production teams is required.

Qualifications

• Education requirements include M.Sc. Organic Chemistry, M.Pharm, or Ph.D. in relevant fields.
• 3–4 years API Process R&D experience in pharma is expected.
• Strong knowledge of GMP/GLP/ICH regulations and quality systems.

Responsibilities

• Develop and optimize synthetic routes for API manufacturing.
• Conduct lab experiments for process development and improvement.
• Prepare batch records, technical reports, and development documentation.
• Support technology transfer to pilot plant and production.
• Ensure compliance with GMP, GLP, and regulatory guidelines.

Skills

Organic chemistry

Process development

Optimization

Laboratory equipment

Impurity profiling

Technology transfer

GMP/GLP/ICH knowledge

Analytical techniques

Documentation

Education

M.Sc. Organic Chemistry

M.Pharm

Ph.D.

Tools

HPLC

GC

LC-MS

NMR

Job description

API R&D Executive / Research Scientist (3–4 Years Experience)

Job Description

Position Summary:

We are seeking a motivated and experienced API R&D professional with 3–4 years of experience in process research and development. The candidate will be responsible for developing and optimizing synthetic processes for APIs, conducting laboratory experiments, preparing technical documentation, and supporting scale-up and technology transfer activities.

Key Responsibilities

• Develop and optimize synthetic routes for API manufacturing.
• Conduct laboratory experiments for process development and process improvement.
• Perform reaction optimization, impurity profiling, and yield improvement.
• Prepare batch records, technical reports, SOPs, and development reports.
• Support technology transfer from R&D to pilot plant and manufacturing.
• Ensure compliance with GMP, GLP, and EHS guidelines.
• Perform literature searches and patent reviews for process development.
• Coordinate with Analytical R&D, QA, QC, and Production teams.
• Investigate process deviations and recommend corrective actions.
• Maintain accurate laboratory documentation and notebooks.

Required Skills

Technical Skills

• Strong knowledge of organic chemistry and API synthesis.
• Experience in process development and optimization.
• Hands-on experience with laboratory equipment and reaction setups.
• Knowledge of impurity identification and control strategies.
• Understanding of technology transfer and scale-up activities.
• Familiarity with GMP, GLP, ICH guidelines, and regulatory requirements.
• Basic understanding of analytical techniques such as HPLC, GC, LC-MS, and NMR.
• Good documentation practices.

Soft Skills

• Strong analytical and problem-solving abilities.
• Good communication and teamwork skills.
• Time management and planning.
• Ability to work independently and meet project deadlines.

Qualifications

• Education: M.Sc. Organic Chemistry / M.Pharm / Ph.D. (preferred for certain roles)
• Experience: 3–4 years in API Process R&D in a pharmaceutical company.

Preferred Experience

• Experience with API process development and optimization.
• Technology transfer to pilot plant or commercial manufacturing.
• Experience in regulated markets (USFDA, EMA, MHRA, etc.) is an advantage.
• Knowledge of Quality by Design (QbD) is desirable.