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Manufacturing Project Lead

1 month ago

Portsmouth NH United States Lonza Full time
United States, Portsmouth (New Hampshire)

Manufacturing Project Lead- Large Scale Allogeneic

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.

View a short video about a career at our Portsmouth, NH facility here: Your Career with Lonza in Portsmouth, NH - YouTube

Lonza is building a dedicated large scale allogeneic product facility for a key customer. The Manufacturing project lead is expected to lead the operational organization in a supervisory capacity during the construction, ramp up and routine GMP manufacturing of the facility. This individual will act as key point of contact to support decisions related to operational aspects during the construction phase and assure that the facility is built according to Lonza's standards.

The Manufacturing Supervisor will provide a safe, controlled work environment in all areas of responsibility. Be aware of the site safety objectives and make sure they are communicated and understood by all staff. Manufacturing Supervisor will act as the Subject Matter Expert in the assigned project / suite during manufacturing operations. The Manufacturing Supervisor will provide in suite oversight of the manufacturing process during critical operations (i.e. harvest, visual inspection, etc.) Work with Internal and Joint Project Teams to transfer in and maintain customer processes in production facility. Attend the IPT, JTT, and as necessary JPT meetings as the manufacturing representative for all ongoing processes. Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. Collaborate with Manufacturing Leadership team to incorporate process and operational improvements into new and existing customer processes in manufacturing. Collaborate with Technical Manager to identify and procure equipment and materials the manufacturing suite requires in order to continually run processes. May be asked to assume responsibilities for covering Manager absences/vacations.

Support the definition and execution of Operational Readiness Activity :
  • Manufacture and Delivery of clinical & commercial material
  • Execution of manufacturing procedures & collaboration with Quality Assurance to execute CGT quality systems aligned with existing operations & finished dose requirements.
  • Provide in-person oversight of the manufacturing operations team.
  • Support the execution of appropriate Safety, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management and EM strategies.
  • Support the definition and execution of all activity in compliance with EHS requirements

Provide oversight and support to the definition and execution of Technology Transfer activities :.
  • Operational input into material requirements, process execution & methods transfer.
  • Operational input into defining & executing manufacturing activity related to Technology Transfers – water runs, training runs, pilot runs, engineering runs etc.
  • Enable timely delivery of milestones for the Technology Transfer.

As project contributor collaborate with CT Manufacturing Leadership Team to ensure:
  • Timely and accurate project progress & tatus
  • Progression of proposals, SOWs and change orders.
  • Appropriate interaction with key external (customer) and internal stakeholders.
  • Perform other duties as assigned.

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: R60621