About this role
Job Description Upstream Manufacturing Operations Execute upstream production activities including: Microbial fermentation operations Seed train preparation and bioreactor inoculation Media and feed preparation Bioreactor monitoring and control Harvest operations (cell separation/primary recovery) Operate and monitor bioreactors (single‑use or stainless steel) and associated systems. Control and record critical process parameters such as pH, DO, temperature, agitation, airflow, and feeding. Perform aseptic operations as per SOPs and batch manufacturing records (BMRs). cGMP Documentation & Compliance Execute manufacturing activities strictly as per cGMP, SOPs, and approved batch records. Complete real‑time documentation in BMRs, equipment logbooks, and process sheets. Identify and immediately report deviations, alarms, contamination risks, or abnormal observations. Support deviation investigations, corrective actions (CAPA), and change control implementation. Equipment & Area Management Perform cleaning, sanitization, sterilization (CIP/SIP), and setup of upstream equipment. Support integrity testing, equipment calibration coordination, and preventive maintenance. Ensure proper handling and storage of media components, supplements, and raw materials. Maintain housekeeping, 5S, and hygiene standards in classified areas. · Coordinate with Downstream, QC, QA, Engineering, and Warehouse teams for smooth batch execution. · Support technology transfer, scale‑up, validation, and engineering batches under guidance. · Participate in training programs to continuously upgrade technical and GMP skills. Technical Skills Hands‑on knowledge of fermentation operations Understanding of seed train, media preparation, and harvest operations Familiarity with bioreactor control systems and process monitoring Basic knowledge of cGMP documentation and aseptic practices Comfortable working in cleanroom and shift‑based operations Work Experience 5 to 8 Years Education Masters in Biotechnology or Microbiology B.Tech in Biochemistry Competencies