Sr. Chemist / Chemist - Production API

Role & responsibilities

• Batch Operations: Execute API manufacturing reactions, charging raw materials, filtration, centrifugation, drying, and isolation processes as per approved Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOP).
• Process Monitoring: Monitor critical process parameters (CPP) like temperature, pressure, pH, and agitation rates closely during synthesis.
• Documentation: Maintain accurate, real-time entries in BMRs, logbooks, and line clearance records to meet audit and regulatory expectations.
• Compliance & Safety: Strictly adhere to Current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Environmental, Health, and Safety (EHS) policies
• Cross-Functional Coordination: Coordinate with Quality Assurance (QA), Quality Control (QC), and Engineering teams for equipment maintenance, change controls, and sample handovers.
• Troubleshooting: Identify operational abnormalities or process deviations on the shop floor and report them immediately to the shift in-charge.

Preferred candidate profile

2 to 5 years of hands-on experience in an USFDA-Approved API or bulk drug manufacturing facility.