Manufacturing Associate / Biotechnologist Associate

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

conditions.

•  Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, and sampling, and conduct routine sanitization tasks to maintain facility and equipment.

• They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic techniques in handling of products and materials.

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents by good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.

• Attain qualification for all assigned tasks and maintain individual training plan.

• Perform basic laboratory tasks, such as monitoring pH, and conductivity, testing product samples, etc.

• Perform material movements, and transfer raw materials, and chemicals into, out of, and across the production areas.

• Maintain facility and equipment through routine cleaning and sanitization, and supported 6S programs.

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

• Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects.

• Perform other duties as assigned