Cell Therapy Manufacturing Associate level 3

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.

You 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. You will be proficient in an assigned area (i.e. Cell Growth, Drug Product Filling, etc.) and work in a team environment during manufacturing operations (i.e. harvest, fill/finish, visual inspection, etc.).  You’ll work with customer SMEs to transfer in and maintain customers' processes in production facility.  Provide/Arrange effective training for manufacturing staff related to any new equipment or systems to be used in Cell Therapy (CT).  Collaborate with CT Manufacturing Leadership team to incorporate process and operational improvements into new customer processes in manufacturing.  Collaborate with CT Manufacturing Leadership team to determine equipment and materials the suite will need to purchase in order to run the process. You may act as a lead role in the absence of the Senior Manufacturing Associate.

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.  BS preferred, additional experience in lieu of degree considered

Qualified individuals will have working experience/working knowledge of the following:

  • Knowledge of cGMP practices preferred
  • Basic principles of hygienic practices and microbiology preferred
  • Familiarity with use of computers
  • Proactive communication
  • Experience with processing in a cleanroom environment
  • 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.

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: R37074