Process R&D Executive / Tech Transfer- API intermediates

Role & responsibilities

1. Conduct laboratory-scale reaction development and optimisation, including reagent, solvent and catalyst selection, to improve process robustness.

2. Execute synthesis, isolation and purification of products and intermediates using standard laboratory techniques, from gram to multi-kilogram scale.

3. Support scale-up of processes from laboratory to pilot and plant scale, providing on-site support for critical operations and troubleshooting.

4. Perform routine in-process analytical monitoring (TLC, HPLC, GC, etc.) to track reaction progress, and interpret and communicate data effectively.

5. Prepare and maintain accurate project documentation, including batch records, development reports and material specifications.

6. Collaborate with AR&D, Quality Assurance, EHS and manufacturing teams to ensure processes are delivered right-first-time.

7. Conduct reaction hazard assessments and contribute to safe process design in line with GLP/GMP requirements.

8. Assist in managing project timelines and resource allocation under the guidance of senior R&D professionals.

9. Investigate and troubleshoot process deviations, contributing insights for continual process improvement. 10. Stay abreast of emerging trends, green chemistry approaches and advancements in the field to identify opportunities for process efficiency.

Preferred candidate profile

1. Candidates with a postgraduate degree in chemistry [M.Sc. (Chemistry)] or B.Tech/M.Tech in Chemical Engineering from a reputed university with strong academic achievements may apply.

2. 3-5 years of relevant experience in Process R&D within the pharmaceutical/API manufacturing industry.

3. Demonstrated experience in synthetic route development, reaction optimisation and lab-to-plant scale-up for APIs and intermediates.

4. Working knowledge of GMP principles and regulatory expectations applicable to API process development.

5. Deep understanding of chemical principles, experimental design and analytical techniques used to monitor reactions.

6. Strong willingness to learn, adapt, and work effectively as part of a cross-functional team.

7. Excellent communication skills, with the ability to present technical findings to both technical and non-technical audiences.

8. Strong problem-solving abilities and a creative mindset to drive innovation and overcome process development challenges.

9. Proven, hands-on experience in preparing and executing technology transfer documentation and coordinating cross-functional transfer activities.

10. Demonstrated technical expertise in technology transfer, combined with a strong ability to evaluate process economics and drive cost-efficiency during bulk-scale manufacturing.

11. Strong working knowledge of GMP principles, safety protocols and regulatory requirements applicable to API and intermediate manufacturing.

12. Demonstrated ability to troubleshoot process and scale-up issues independently, with minimal supervision.