Manufacturing Associate Level 1 - Cell Therapy

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

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 responsibilities:

  • Execution of manufacturing procedures & collaboration with QA to support CT1 quality systems aligned with existing operations & finished dose requirements.

  • Support the delivery of clinical & commercial material as required.

  • Execution of appropriate Safety, Training, Gowning, Material Movement, Visual Inspection, APS, Cleaning, Scheduling, and EM strategies.

  • Execution of all activity in compliance with EHS requirements.

  • Operational input into material requirements, process execution & methods transfer.

  • Execution of manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.

  • Enable timely delivery of milestones for the Technical Transfer.

  • Author, review, and approve documentation (electronic batch records, SOPs, WIs, and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required.

  • Perform other duties as assigned.

Key requirements:

  • High School Diploma or Equivalent minimum;  AS/BS preferred

  • Preferred area of study:  Science related discipline

  • Entry to Intermediate level of experience in a manufacturing setting preferred

  • Proven logic and decision making abilities, critical thinking skills

  • Strong written and verbal communication skills are required

  • The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities.  Is open to and actively seeks out feedback on their performance and translates that feedback into action.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R36792