Process Validation Lead Scientist (Study Director)

United Kingdom, Slough

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.

We are currently looking to hire an experienced downstream purification Lead Scientist / Viral Clearance Study Director to join our global Viral Clearance team in Slough.

The Lead Scientist / Study Director is a key member of the team working in collaboration with our external vendors to validate the capability of the downstream purification process to remove or inactivate viruses according to regulatory guidelines. You will plan the experimental work, write, and review protocols and reports and troubleshoot technical issues identifying solutions to problems. As a Lead Scientist, you will become an early and late phase Viral Clearance Study Director and subject matter expert in process validation and study management.

You will have opportunity to collaborate with peers in your own team and other teams to ensure that projects adhere to agreed experimental plans and timelines, to deliver a high-quality study following all safety and quality procedures and will also work closely with customers to resolve complex issues by understanding needs, plan experimental work that meets customer expectations, present progress on project stages and respond to customer questions.

This is a great opportunity if you are looking to move into a primarily desk-based role with technical troubleshooting and project management opportunities.

Key responsibilities:

  • Competently lead and be accountable for the design, execution and delivery of multiple projects (safety, quality, right first time, on time) including completion of project dashboards

  • Escalate risks and issues in a timely fashion (technical, resource, customer, cost)

  • Collate and critically analyse information and drive good quality, data driven decisions on own projects

  • Operate as part of a cross-functional project team and liase with external vendors

  • Completion and peer review of internal and external documentation 

  • Prepare and deliver presentations and reports for internal use and for customers

  • Actively participate in scientific discussions and lead problem solving / trouble shooting / lesons learned activities

  • Coach, mentor and train more junior members of the department as required

  • Identify and implement technical and operational improvement projects

  • Accountable for customer proposals (technical content and man-days)

  • Develop an awareness of core project activities outside own area of expertise

Key Requirements:

  • BSC qualified or equivalent in relevant scientific / technical discipline

  • Previous experience in protein purification including chromatography and use of AKTA systems

  • Previous experience in viral clearance including viral inactivation and nanofiltration

  • Working experience within an industrial Laboratory environment

  • Previous experience of working in a GLP/GMP environment

  • Candidates must have a good attention to detail and be able to work as a cross-functional team

  • Evidence of driving projects to completion following project timelines

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.

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Reference: R44866
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