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 Cell Therapy Manufacturing Manager 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 Manager will act as the Subject Matter Expert in the assigned area (i.e. Cell Growth, Drug Product Filling, etc.) during manufacturing operations until the manufacturing staff is fully proficient.

The Manufacturing Manager will provide a in suite oversight of the manufacturing process during critical operations (i.e. harvest, vial filling, visual inspection, etc.)

Work with Internal and Joint Project Teams to bring on and maintain customers' processes in production facility. Responsible for all tech transfers from a manufacturing standpoint. Attend the IPT and JPT meetings as the manufacturing representative for all processes during campaign preparation.

Manufacturing Manager must attend the lessons learned events for the Cell Therapy area and own actions for manufacturing. Own and manage planned deviations and change controls related to start-up of Cell Therapy.

Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. Collaborate with Manufacturing Supervisor(s) to incorporate process and operational improvements into new customer processes in manufacturing. Collaborate with Senior Manufacturing Manager to determine equipment and materials the suite will need to purchase in order to run the process.

Provide input to Head of Emerging Technology for CAR on behalf of manufacturing prior to CAR approval.

May act as fill in for Senior Manufacturing Manager in their absence

Support the definition and execution of Operational Readiness Activity for all Emerging Technology projects at LPO to include.

• Set up of manufacturing procedures & collaboration with QA to develop & execute ET quality systems aligned with existing operations & finished dose requirements.
• Support building & establishing the manufacturing team.
• Delivery of clinical & commercial material as required.
• Support the development and execution of appropriate Safety, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management and EM strategies.
• Definition and execution of all activity in compliance with EHS requirements.Provide oversight and support to the definition and execution of Technical Transfer activities for Cell Therapy Projects at LPO 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.
• Co-ordination with Portsmouth Mammalian Operations and customer technical team.
• As project contributor collaborate with Head of Emerging Technology and Senior Manager to ensure.
• Timely and accurate financial reporting of project progress & revenue status
• Progression of proposals, SOWs and change orders.• Appropriate interaction with key external (customer) and internal stakeholders.
• Support of the wider Emerging Technology network to include.
• Provide input to the preparation of operational models and costs to support the proposal process• •
• Supporting process Improvements, risk mitigation and training opportunities as appropriate.

Skills

• Direct interaction with regulatory agencies
• Core involvement in Technical Transfer and project activity
• Leadership of organizational change, staff hiring and training
• Continuous Improvement activities
• Generation and optimization of electronic batch documentation
• Experience of biological manufacturing operations - Fermentation, Purification, Drug Product Filling and Freezing processes.
• Experience operating automated Drug Product Filling machines using RABS and/or Isolator technology
• Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred
• Experience of automated and manual visual inspection systems preferred.
• Solid staff management experience and proven ability to manage budgets.
• Ability to work inter-departmentally and potentially with customers.
• Excellent leadership skills a must.

Reference: R62956