Manufacturing Supervisor (Nights) - Cell Therapy

Lonza•Portsmouth, NH

About The Position

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 idea, big and small, genuinely improve the world, and that’s the kind of work we want to be a part of. The Manufacturing Technical Supervisor will provide a safe, controlled work environment in all areas of responsibility. He or she must be aware of the site safety objectives and make sure they are communicated and understood by all staff. The Manufacturing Technical 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 Technical Supervisor will provide 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. The Manufacturing Technical Manager must attend the lessons learned events for the Cell Therapy (CT) 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. May be required to provide input to Head of Emerging Technology and/or Senior Manager for budgetary/financial planning. May act as fill in for Senior Manufacturing Manager in their absence.

Requirements

Related working knowledge with degree, significant work experience without degree required
BS Preferred, additional experience in lieu of degree considered
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 Isolator technology
Solid staff management experience and proven ability to manage budgets.
Ability to work inter-departmentally and potentially with customers.
Excellent leadership skills a must.

Nice To Haves

Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred
Experience of automated and manual visual inspection systems preferred.

Responsibilities

Support the definition and execution of Operational Readiness Activity for all Emerging Technology projects at Lonza Portsmouth (LPO) to include.
Set up of manufacturing procedures & collaboration with Quality Assurance (QA) to develop & execute 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, Cleaning, and Scheduling.
Support the definition and execution of all activity in compliance with environmental health and safety (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.
Coordination with Portsmouth Mammalian Operations and customer technical team.
Timely and accurate financial reporting of project progress & revenue status
Progression of proposals and change orders.
Appropriate interaction with key external (customer) and internal stakeholders.
Perform other duties as assigned.