Lonza
R71608 Viral Vector Manufacturing Project Specialist (Evergreen)
Today, Lonza is a global leader in life sciences operating across five 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.
Key responsibilities:
Lead and manage viral vector manufacturing projects from concept to completion, including technology transfers, capital projects, campaign support, and manufacturing initiatives.
Own and drive improvement initiatives that align with department KPIs, focusing on quality, cost reduction, efficiency, innovation, on-time delivery, and right-first-time performance.
Manage and monitor key processes such as CAPAs, planned deviations and change controls, to ensure compliance and timely closure.
Collaborate cross-functionally with internal teams (MSAT, Engineering, Validation, PD, PM, Supply Chain etc.), customers, and manufacturing suites to develop or update policies, procedures, and best practices.
Review deviation investigation reports, validation protocols as part of ongoing process and quality control.
Monitor and support the timely closure of CAPAs and deviations, ensuring proper escalation and follow-up on overdue tasks.
Provide leadership and mentorship to core technicians and other teams as applicable, including training impacted areas on new processes or procedures.
Ensure effective communication of project status, risks, and changes to stakeholders, ensuring alignment with overall project goals and objectives
Support manufacturing readiness, ongoing operations, and continuous improvement efforts.
Key requirements:
5 years' manufacturing experience.
In-depth technical knowledge of small and large scale (50L, 250L and 2KL) viral vector manufacturing processes, operations, and equipment.
Experience in technology transfer processes and campaign readiness.
Strong understanding of batch record procedures and other essential documentation required for manufacturing execution.
Proficient in Quality Systems (e.g., deviations, change controls, TrackWise etc) and practical application in manufacturing operations.
Solid knowledge of process, equipment, cleaning, and computer system validations, with the ability to review and approve protocols and reports, and support new equipment implementation.