Lead Scientist (DSP development/ characterisation)

United Kingdom, Slough

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 ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The purpose of this position is to provide scientific leadership on projects including but not limited to standard monoclonal antibody purification process, purification, process transfers (from Customer or between Lonza sites), recombinant purification process development, Downstream process characterisation and process validation studies to support License Applications. You will be required to proactively identify opportunities for process improvement and lead specific improvement projects. You will represent Purification Development at project team and Customer meetings and take an active role in the generation of Proposals for new and existing Customers.

Key responsibilities:

  • Application of regulatory guidelines to experimental design
  • Design and execution of standard and non-standard mAb Evaluations
  • Design and lead bespoke and complex stages or projects
  • Responsible for execution of Laboratory work for own project or to support others
  • Competently plan and direct the work of others
  • Coach, mentor and train more junior members of department as required
  • Study Director for Process Characterisation Studies and Validation Studies
  • SME for regulatory inspections
  • Established as SME in particular area
  • Competently lead and be accountable for the delivery of multiple projects (focusing on safety, quality, right first time, on time delivery) and additional responsibilities to agreed timelines including creation and completion of project dashboards
  • Collate, analyse and evaluate data from work / study programs and offer advice when required
  • Write, review and critique reports to an agreed standard suitable for final review by Head of Department
  • Prepare and deliver presentations, protocols and reports with right first time quality
  • Engage with Customers to demonstrate Lonza’s scientific credibility and grow relationships
  • Escalate risks and issues in a timely fashion (technical, resource, Customer, cost)
  • Lead problem solving / trouble shooting / lessons learned activities
  • Primary technical contact for Customers for ongoing projects and Develop Customer relationships Engage with Customers to demonstrate Lonza’s scientific credibility and grow relationships
  • Role model for communication, best practise and behaviour within Process Development
  • Input into Customer proposals (technical content and man days)
  • Identify opportunities and pproactively input into departmental and process improvements and lead specific improvement projects and investigations
  • Proactive approach to own continuous professional development
  • Conduct Customer Laboratory Tours
  • Represent Lonza externally
  • Demonstrate flexibility to support other activities within the team/department
  • On call rota
  • System maintenance / System owner
  • Deviation writing
  • Raise and Lead equipment Change control
  • Execute allocated duties consistent with cGMP and EHS policies and standards
  • Maintain required training and skills to execute duties
  • Contribute to departmental training
  • Demonstrates a high level of independence
  • Manage and prioritise multiple tasks

Key requirements:

  • Phd or BSc in relevant scientific / technical discipline and appropriate experience
  • In depth knowledge of all relevant service offerings
  • The ability to assimilate complex information and draw insightful conclusions
  • Established credibility within the Lonza network or broader scientific network
  • Keen appreciation of commercial requirements
  • Ability to set clear direction and goal
  • An excellent understanding of the theory and practice of protein purification and protein structure is required
  • In depth theoretical knowledge and practical experience in downstream processing e.g; AKTA Chromatography systems, Ultra-filtration, high throughput resin screening etc
  • Experience in purification of recombinant proteins (including but not limited to monoclonal antibodies)
  • Some knowledge of GLP/GMP or similar quality systems
  • An awareness of technology transfer of processes from laboratory scale to manufacturing plants.
  • Process Validation experience in line with current regulatory guidelines

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.

Reference: R23432