Head of Method Validation

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 for an experienced Head of Method Validation to join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.

Reporting to the Head of Quality Control, this role is responsible for devising and implementing the long-term vision and strategy for a dynamic and expanding method validation team, based in Slough, validating phys/chem methods and bioassays.

The person will be responsible for ensuring flawless execution of platform method evaluations, validating new methods and maintaining platform methods in line with regulatory expectations.  The person will also be responsible for delivering the strategy for implementing new analytical technologies and automation. The individual will also ensure laboratory compliance / adherence to GMP and Lonza Quality standards. It is expected that lean lab principles will be used to deliver testing and that a continuous improvement mindset is embedded within the organisation.

Key responsibilities:

  • Developing and delivering the long-term vision of the Method Validation department and supporting the QC strategy and vision, including the transition to non-mAb testing, implementing new technologies and automation to increase throughput
  • Ensure that the laboratories are compliant and host customer / regulatory audits as required
  • Responsible for the scientific and financial success of the department
  • Provide leadership for the development of technical and scientific capabilities to improve/maintain quality of study activities delivered to Customers
  • Identify and deliver work packages in support of drug development and commercial programs
  • Devise and deliver the scientific road map for the department
  • Develop and implement efficient work processes across the department, e.g. Lean Lab, 6S and continuous improvement
  • Control, monitor and take action on financial aspects of the department (revenue, profitability, spend and variances)
  • Prioritise (with input from key stakeholders) studies and resources for on time delivery of work
  • Define and maintain headcount and lab resources within 10 % of agreed targets
  • Use regulatory knowledge to ensure that appropriate data is provided for IND/BLA submissions and that methods comply with guidelines
  • Be fully aware of and able to further improve GMP systems as applied to validating and maintaining methods through their lifecycle
  • Present and represent the Department and the wider QC department / services to Customers, potential new customers, external meetings and other Lonza sites
  • Provide coaching, mentoring and training to ensure that the team have the required skills and to ensure that team members are developed.

What we need you to have:

  • BSc/MSc or PhD Qualified within Biotechnology/Pharmaceutical
  • Extensive experience within Analysis/Development/Manufacture of large molecule drug substances/products.
  • Will have a Business Improvement mindset.
  • Previous leadership experience, this role will have 6-9 direct reports and 35-40 indirect reports.
  • Strong project management skills and understanding of the wider business and connectivity, in order to ensure that projects are delivered on time and in full, within budget and meeting the agreed objective.
  • Previous experience working across multiple sites and advantage.

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: R43500