Manufacturing Associate

Job Description:
The Manufacturing Associate I is responsible for supporting the production of therapeutic proteins (Active Pharmaceutical Ingredients API) under strict cGMP conditions. This entry level role involves executing manufacturing processes, operating and monitoring equipment, performing basic laboratory tasks, and maintaining a clean and compliant production environment. The associate will work under close supervision while developing proficiency in aseptic technique, documentation practices, and regulated manufacturing operations.

This position is ideal for individuals beginning their career in biotechnology, pharmaceuticals, or life sciences manufacturing.
Roles & Responsibilities:
Production Operations:

• Operate and monitor manufacturing equipment.
• Perform CIP/SIP activities.
• Follow batch records, SOPs, and GMP/GDP documentation.

• Complete required training modules.
• Maintain an active training plan and task qualifications.

• Perform basic tests (pH, conductivity).
• Collect and handle samples using aseptic technique.

• Move raw materials and chemicals across production areas.
• Support material staging and inventory flow.

• Clean equipment and production areas.
• Support 6S and housekeeping standards.

• Attend shift handovers and meetings.
• Manage emails and routine documentation.
• Support projects and other assigned duties.

• Minimum:
  High School Diploma or Equivalent.
• Preferred:
  Associate or bachelor's degree in a science related field (Biology, Chemistry, Biotechnology, etc.)
• 0 3 years of experience in manufacturing, biotech, pharmaceutical, or related environment.
• Prior exposure to GMP, cleanroom operations, or laboratory work preferred.
• Experience with equipment operation, documentation, or basic lab techniques is an advantage.

• CGMP regulated cleanroom environment.
• Requires wearing PPE, including gowns, gloves, safety glasses, etc.
• Standing, walking, and light material handling required.
• Exposure to chemicals, biological materials, and controlled environments.