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 1 will help to provide a safe, controlled work environment in all areas of expertise. Be aware of the site safety objectives and make sure they are communicated and understood. Manufacturing Associate Level 1 will work to be proficient in an assigned area and work in a team environment during manufacturing operations (i.e. harvest, fill/finish, visual inspection, etc.).  Work with Technical Transfer Subject Matter Experts (SMEs) to transfer in and maintain customers' processes in production facility.  Become proficient in assigned trainings related to any new equipment or systems to be used in Cell Therapy (CT). Work to develop documentation and trainings on any new equipment to be used in Cell Therapy. Collaborate with CT Manufacturing team to incorporate process and operational improvements into new customer processes in manufacturing.  Collaborate with CT Manufacturing team to determine equipment and materials the suite will need to purchase in order to run the process.

Key Responsibilities:

  • Support the definition and execution of Operational Readiness Activity for the Cell Therapy Site projects at LPO to include:

  • Set up of manufacturing procedures & collaboration with Quality Assurance (QA) to support CT quality systems aligned with existing operations.

  • Support building & establishing the manufacturing team by participating in the training of new colleagues.

  • Complete the appropriate Safety, Gowning, Material Movement, Visual Inspection, APS, Cleaning, Scheduling, and Environmental Monitoring (EM) Trainings.

  • Author, review, and approve documentation (Batch Records, SOPs, WIs, LQMs, PMs and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required.

  • Support the definition and execution of all activity in compliance with Environmental Health & Safety (EHS) requirements.

  • Manufacturing readiness to include staying up to date with training, compliance wire, iComply, and other relevant assignments.

  • Cleaning of manufacturing spaces and ensuring manufacturing space is ready for use.

Key Requirements

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

  • Working experience/knowledge; some prior experience in a manufacturing setting preferred.

  • Support the definition and execution of Technical Transfer activities for the CT projects at LPO to include:

  • Operational input into executing manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.

  • Work to complete timely delivery of milestones for the Technical Transfer schedule.

  • Learning process flow, theory and implementation strategy of customer processes that are being transferred to the LPO CT facility.

  • Attend customer site visits, collect data and process information to be incorporated into LPO site processes

  • As project contributor collaborate with CT Manufacturing Leadership Team to ensure:

  • Timely updating of relevant project metrics

  • Appropriate interaction with assigned internal stakeholders (i.e. MSAT, QA, QC, etc.).

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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R36818