Job Description

This role supports execution of API manufacturing operations by performing process activities and ensuring accurate documentation in a regulated production environment. The role involves operating process equipment and executing batch manufacturing steps such as charging, reaction monitoring, filtration, drying, and material transfers in accordance with batch manufacturing records and standard operating procedures. The incumbent handles raw materials and intermediates while ensuring adherence to GMP, safety, and quality standards. It maintains accurate and timely documentation of all manufacturing activities to ensure traceability and audit readiness. The role contributes to consistent batch execution, regulatory compliance, and operational efficiency while supporting continuous improvement initiatives in API manufacturing processes.

Essential Functions:

• Execute API manufacturing activities (charging, reactions, filtration, drying, material transfers) as per batch manufacturing records

• Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines

• Operate process equipment such as reactors, centrifuges, dryers, and filtration systems in compliance with SOPs

• Handle raw materials, solvents, and intermediates in line with GMP and safety requirements

• Record process parameters, observations, and activities accurately in batch documentation

• Ensure adherence to cGMP, safety guidelines, and regulatory requirements during all operations

• Perform equipment cleaning, line clearance, and basic maintenance as per defined procedures

• Maintain cleanliness, housekeeping, and safe working conditions in manufacturing areas

• Identify and report process deviations, abnormalities, and safety concerns promptly

• Support in-process checks and sampling to ensure product quality and consistency

• Participate in process improvement, yield enhancement, and operational efficiency initiatives

Additional Responsibilities:

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 1 year or more in 1 - 4 Years