Officer

2–5 years of relevant experience in API process development, R&D, or analytical/process laboratory operations

Qualification
M.Sc. / M.Pharm / B.Pharm / B.Tech in Chemical Engineering or related discipline.

Experience in API process development is preferred.

Job Purpose
To support process development, optimization, scale-up, and technology transfer activities for API products. The role involves laboratory experimentation, process evaluation, data generation, documentation, and coordination with analytical, production, and quality teams.

Key Responsibilities
Process Development
Execute laboratory experiments for API process development and optimization under defined protocols.

Support development and optimization of synthetic processes for API and intermediates.

Study reaction parameters such as temperature, pH, reaction time, solvent, reagent quantity, and process conditions.

Perform experiments for improving yield, purity, cycle time, and process robustness.

Conduct laboratory trials for process improvements and troubleshooting.

Laboratory Activities
Perform reactions and laboratory-scale experiments safely and accurately.

Handle laboratory equipment such as reactors, filtration systems, centrifuges, dryers, distillation setups, and other process-development equipment.

Prepare samples and coordinate with the analytical team for testing.

Record experimental observations, results, calculations, and conclusions accurately.

Maintain laboratory housekeeping and ensure proper handling and storage of chemicals and samples.

Process Optimization & Scale-Up
Support process optimization and scale-up activities from laboratory scale to pilot/plant scale.

Generate process-development data required for scale-up and technology transfer.

Identify potential process risks and recommend suitable control strategies.

Participate in plant trials and provide technical support during process execution.

Support troubleshooting of process-related issues during scale-up and commercial manufacturing.

Documentation
Prepare and maintain laboratory notebooks, experimental reports, batch/process records, and development reports.

Prepare experimental protocols and summarize results and conclusions.

Ensure all documentation complies with applicable GMP, GLP, SOP, and data-integrity requirements.

Maintain proper traceability of samples, raw materials, chemicals, and experimental data.

Support preparation of process-development and technology-transfer documents.

Safety & Compliance
Follow laboratory safety procedures and applicable EHS requirements.

Ensure proper handling of hazardous chemicals, solvents, gases, and reactions.

Use appropriate PPE and follow chemical-waste disposal procedures.

Report incidents, deviations, and unsafe conditions promptly.

Maintain compliance with company SOPs and quality systems.

Cross-Functional Coordination
Coordinate with Analytical R&D, Production, QA, QC, Engineering, and other departments.

Provide technical information and experimental data to support manufacturing and technology-transfer activities.

Participate in project meetings and provide updates on assigned development activities.

Required Skills
Good understanding of organic chemistry and API manufacturing processes.

Practical knowledge of API process development and optimization.

Good understanding of reaction chemistry, crystallization, filtration, drying, extraction, and solvent recovery.

Ability to analyze experimental results and identify process improvement opportunities.

Good documentation and technical-report writing skills.

Knowledge of GMP/GLP and data-integrity principles.

Strong laboratory safety awareness.

Good communication and teamwork skills.

Key Performance Indicators (KPIs)
Timely completion of assigned development experiments.

Successful process optimization and improvement.

Quality and accuracy of experimental data.

Timely preparation of development reports and documentation.

Successful scale-up and technology-transfer support.

Compliance with GMP, GLP, SOP, EHS, and data-integrity requirements.

Reduction in process cycle time, cost, and variability