Job Description
Job Description
The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, 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 technique in handling of products and materials.
Key Accountabilities
- 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 in accordance with 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 monitor pH, conductivity, test product samples, etc.
- Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
- Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
- Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects.
- Perform other duties as assigned.
Notes: This role is A Night Shift. This means they will alternate weeks. One week is Monday Tuesday Friday Saturday Sunday, and the next week is Wednesday Thursday. Night shift is 1830 - 0630. Please ensure candidates understand the working shift requirements.
This is an DownStream MFG role, involving buffer prep, and working with chemicals