Manufacturing Associate - Biotech

Role Purpose

The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions.

Responsibilities

• Execute process recipes and follow written procedures (SOPs).
• Maintain equipment and processes.
• Perform basic laboratory tasks (e.g., pH, conductivity, sampling).
• Conduct routine sanitization tasks to maintain facility and equipment.
• While training under close supervision, demonstrate aseptic techniques and build a basic understanding of cGMP compliance.
• Set up, operate equipment, and monitor production processes, including CIP (Clean-in-Place) and SIP (Steam-in-Place).
• Document production in accordance with GMPs and GDPs.
• Review documentation as needed.
• Attain qualification for all assigned tasks and maintain individual training plan.
• Perform basic laboratory tasks such as monitoring pH, conductivity, and testing product samples.
• Perform material movements, including transferring raw materials and chemicals into, out of, and across production areas.
• Maintain facility and equipment through routine cleaning/sanitization and support 6S programs.
• Attend shift exchange, meetings, handle email communication, participate in projects, and perform other duties as assigned.

Qualifications

• Education: High School Diploma or Equivalent required; AS/BS in a science-related discipline preferred.
• Experience: 0-3 years; prior experience in a manufacturing setting preferred.
• Skills: Proven logic and decision-making abilities, strong critical thinking skills.