Job Description

Key responsibilities of the position include, but are not limited to:

• Accurately weigh, measure, mix, and sterile filter cell culture media and buffer solutions within a cGMP environment.
• Strictly follow current Good Manufacturing Practices (cGMP), adhere to all standard operation procedures (SOPs), comply with all company policies, and data integrity standards.
• Execute associated batch records in real-time as well as associated supporting documents/logbooks. 
• Ensure batches are executed in a timely manner and maintain proper documentation practices. 
• Conduct routine sampling and support in-process testing and perform Daily in-process monitoring throughout batch duration. (pH, metabolites, cell density/viability).
• Use various analytical equipment such as pH meter, conductivity meter, osmometer, scales, etc.
• Performing equipment troubleshooting, cleaning, verification, and status labelling.
• Use of programs to collect, evaluate, and review operating data to conduct on-line adjustments to instruments or equipment. 
• Ability to interpret and provide instructions furnished in written, oral, diagram, or scheduled format. 
• Coordinate/support with the conduction of investigations and corrections for related issues during batch execution. 
• Maintain good housekeeping standards in the work area.
• Following safety procedures specific to work area, including the proper use of personal protective equipment. 
• Demonstrating dependability through good attendance and adherence to timelines and schedules.
• Perform other functions as required or assigned to support manufacturing operation. 

QMS, Documentation, and Compliance

• Write, revise, and execute manufacturing batch records, SOPs, Protocols and logbooks.
• Assist with opening/closing deviations, CAPAs, change controls, and investigations.
• Support quality audits and regulatory inspections.
• Ensure all operations comply with cGMP, safety, and data integrity standards.

Material & Inventory Management

• Track, request, and stage raw materials including media components, consumables, and gases.
• Perform label verification, receipt checks, and electronic inventory updates.
• Coordinate with warehouse and planning teams for material readiness.

Cross-Functional & Technical Transfer Support

• Collaborate with supporting groups such as QA, Analytical, Engineering, and Validation groups.
• Support technology transfer of new upstream processes or scale changes.
• Perform small projects independently and contribute to larger tech-transfer initiatives.
• Generate work orders and follow up in case of machine breakdown.