Study Director/Technical Reviewer - 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.

Here at Lonza Slough, we have an amazing opportunity for a Lead Scientist/Study Director to join our world leading Characterisation Team. Study Director and Technical Reviewer for the characterisation and comparability of therapeutic proteins to cGMP.  Ownership of characterisation stages of work, including writing and review of protocols and reports, reviewing associated data and technical oversight.  Review of assays for the Characterisation team as a whole.  Assays to review include: electrophoresis (e.g. SDS PAGE, CE SDS, icIEF), HPLC (e.g. GPC, IEX, peptide map and oligosaccharide analysis), circular dichroism, FT-IR, AUC and mass spectrometry-based methods.  The person will be mainly office based, however, will also be expected to observe assays performed by other analysts in the laboratory and provide technical support.  All work is expected to be carried out in a safe and compliant manner

Key responsibilities:

  • Study Director for stages of work within Characterisation.  Responsible for the planning, protocol, data and associated report content and on time delivery for the given studies.
  • Performs technical review of assays performed for characterisation and comparability studies, which are carried out against standard operating procedures, protocols and GMP principles.
  • Plans and completes assigned tasks within the required timeframe.
  • To assigning assays for technical review to the team and manage the timeline to ensure delivery to the teams priorities.
  • Liaise with operators and other Study Directors to close out technical review of assays. Assays to review include: electrophoresis (e.g. SDS PAGE, CE SDS, icIEF), HPLC (e.g. GPC, IEX, peptide map and oligosaccharide analysis), circular dichroism, FT-IR, AUC and mass spectrometry-based methods
  • Communicate progress and escalate challenges to Line Manager and/or scientific lead as appropriate.

Key requirements:

  • Good understanding of protein biochemistry, complex protein characterisation, and the analytical methods used to elucidate their structure and associated post-translational modifications
  • Extensive cGMP experience, knowledge of regulatory expectations in relation to therapeutic proteins and how adherence to GMP impacts the way we work
  • Experience writing and reviewing quality records e.g. deviations, OOS, OOT
  • Excellent organization, time management and prioritization skills
  • Ability to make informed, quality based decisions
  • Able to make quality decisions based on the best available scientific data
  • Desire to learn and a willingness to impart knowledge
  • Confident and resilient enough to thrive in a challenging environment

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.

Opening Date: 29.10.2020

Closing Date: 26.11.2020

Reference: R24813