Upstream Pilot Plant Associate

Duration- 6 months with the possibility of extension or conversion to FTE

Upstream Pilot Plant Associate Qualifications :

• Execute upstream processes, including cell culture expansion, bioreactor operations (bench, pilot, and production scales), and media / buffer preparation.
• Operate and maintain upstream bioprocessing equipment such as wave / rocking platforms, stirred-tank bioreactors, incubators, and automated control systems.
• Prepare, sterilize, and manage cell culture consumables while ensuring aseptic technique in all operations.
• Maintain strict adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, technology transfer documents, and campaign summary reports.
• Ensure compliance with company SOPs, training requirements, and best practices for scale-up and technology transfer.
• Maintain facility readiness and support inspections through vigilant oversight of upstream operations.
• Utilize Quality Systems and Enterprise Resource Planning (ERP) tools to record and track production activities.
• Provide upstream process subject matter expertise and take ownership of assigned deliverables.
• Demonstrate strong technical writing and communication skills.
• Always maintain a safe working environment and remain current with assigned training.

Preferred : Experience conducting manufacturing investigations in biologics or cell culture based production.