The Manufacturing Associate, Level I, 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 I, 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 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. 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.

The Day shift is from 7am-7pm, on a rotational schedule every other week:

• Week 1: M/T/F/SAT/SUN

• Week 2: W/TH

Key responsibilities :

• Support the definition and execution of Operational Readiness Activity for the Cell Therapy project at Lonza to include:

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

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

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

  • Support the development and execution of appropriate Safety, Training, Gowning, Material Movement, Visual Inspection, Cleaning, and Scheduling.

  • Support the definition and execution of all activity in compliance with environmental health and safety (EHS) requirements.

• Support the definition and execution of Technical Transfer activities for the Cell Therapy project at Lonza to include:

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

  • Operational input into defining & executing 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, work instructions, and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required

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

  • Timely tracking of relevant project metrics

  • Progression of necessary purchase requisitions/orders and tracking through delivery

  • Appropriate interaction with assigned external (customer) and internal stakeholders.

  • Perform other duties as assigned.

Key requirements:

• High School diploma or equivalent required. B.S. preferred, additional experience in lieu of degree considered

• Knowledge of cGMP / GMP practices highly preferred

• Basic principles of hygienic practices and microbiology preferred

• Familiarity with use of computers

• Proactive communication

• Experience with working in a cleanroom environment is highly preferred

• Ability to follow and comply with detailed procedures

• Experience of biological manufacturing operations preferred.

• Ability to work inter and intra-departmentally and potentially with customers.

• Ability to work in a team environment. Ability to strive in challenging situations.

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.