Role Purpose:

To support Drug Substance (DS) and/or Drug Product (DP) operations by assisting in day-to-day execution, documentation, sampling, basic data analysis, and adherence to GMP and EHS requirements, ensuring safe, consistent, and high-quality manufacturing operations.

Key Responsibilities:

• Adhere to GMP, EHS, and site-specific procedures, including compliance with gowning, aseptic/cleanroom practices (where applicable), and safety requirements.
• Execute assigned activities as per approved SOPs, BMR/EBR, batch records, and logbooks, ensuring right-first-time and accurate documentation.
• Support deviation reporting, preliminary investigations, and data collection for Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) under supervision.
• Assist in process monitoring by recording operational parameters, performing basic data trending, and promptly escalating abnormalities or deviations to senior team members.
• Support technology transfer, scale-up activities, and process improvement initiatives by preparing materials, compiling data, and assisting in execution of experiments or trials.
• Coordinate with cross-functional teams such as QA, QC, Engineering, and Warehouse to support routine operational requirements.
• Participate in required trainings, maintain training records, demonstrate learning agility, and show readiness to work in shifts or roster-based operations as required.

Job Qualifications:

• Educational Qualification: BSc / MSc in Biotechnology, Microbiology, Biochemistry, Chemical Engineering, Life Sciences, Chemical Engineering or related disciplines.
• Experience: 0–1 year of experience. Fresh graduates are encouraged to apply. Relevant internships, industrial training, or academic projects will be an added advantage.
• Basic understanding of bioprocessing operations, GMP documentation practices, and contamination control (especially for DP / aseptic environments).
• Working knowledge of MS Excel, data entry, and basic data trending or reporting.
• Strong attention to detail with a high level of discipline in documentation.
• Good communication skills and the ability to work effectively in a team-oriented environment.
• Willingness to learn, adapt, and work in a regulated manufacturing environment.