Biotechnologist Associate - Day Shift

Biotechnologist / Manufacturing Associate - Day Shift

Shift Details: 12-Hour Shifts, Days (7:00 AM - 7:00 PM). Shift details to be provided.

Summary

The Biomanufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes, follow written procedures (SOPs), and ensure adherence to quality standards.

Key Responsibilities

• Process Execution & Monitoring:
• Set up, operate equipment, and monitor production processes, including Clean-In-Place (CIP) and Steam-In-Place (SIP) operations.
• Perform basic laboratory tasks, including pH, conductivity, and sampling.
• cGMP & Documentation:
• Report production in written and electronic documents in accordance with Good Manufacturing Practices (GMPs) and Good Documentation Procedures (GDPs).
• Review documentation as appropriate.
• Attain a basic understanding of cGMP compliance while training under close supervision.
• Facility & Equipment Maintenance:
• Conduct routine sanitization tasks to maintain facility and equipment.
• Maintain facility and equipment through routine cleaning and sanitization, supporting 6S programs.
• Material Handling:
• Perform material movements; transfer raw materials and chemicals into, out of, and across the production areas.
• Training & Compliance:
• Attain qualification for all assigned tasks and maintain an individual training plan.
• Demonstrate aseptic technique in the handling of products and materials.
  

Work Environment

• Must be willing to gown and work in a "clean room" environment.
  
  

Administrative Duties

• Attending shift exchange and meetings.
• Sending/receiving emails.
• Participating in projects.
• Perform other duties as assigned.