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Well Characterized Biologics & Biological Assays
Well Characterized Biologics & Biological Assays is now part of BioProcess International
September 23-26, 2024Hynes Convention Center in Boston, USA

Kristen Nields
Senior Scientist at The Janssen Pharmaceutical Companies of Johnson & Johnson


Kristen started her scientific career at SmithKline Beecham and joined Janssen in 2002 as part of the PRD DMPK organization utilizing LC/MS for FIH metabolite ID. In 2007, she received a technology innovation award from Janssen for her efforts developing a rapid cohesive LC/MS method for first-in-human metabolite identification.

In 2007 Kristen left JNJ and worked at both Merck and GSK while obtaining her PhD from the University of Sciences in Philadelphia. In 2014 she rejoined the Janssen organization and 2020 moved into the cell line engineering and early development organization (CEED).Within CEED Kristen has taken on a role in the newly established cross-divisional E2E team supporting internal programs. She was also selected to be the CDS analytical liaison to partner companies supporting externalized CLD programs. Kristen has provided a much-needed bridge between the mass spectrometry and product quality functions within CDS resulting in greater levels of communication and knowledge sharing in the group. Kristen is also an effective mentor who supports the development of more junior team members as well as supporting a Janssen post doc and co op.

Kristen is a member of the external industry interest group BioPhorumon the analytical subgroup and presents scientific results both inside and outside of the company at national conferences. Over the last year, Kristen has led an external collaboration with Sciex to evaluate a new technology for capturing MS data from a cIEF separation. Rapid MS-based identification of charge variants is a current gap across the entire organization; typically requiring the use of cation-exchange chromatography-based fraction collection followed by MS acquisition. The Sciex technology holds the promise of providing MS-based identification of charge variants in a fraction of the time by coupling cIEF directly to a mass spectrometer. Kristen provided major input into the design of experiments related to the Sciex collaboration and her in-lab activities contributed highly to a successful beta testing cycle.

Agenda Sessions

  • Characterizing Color by online cIEF/MS and Peptide Mapping as a Result of Process Intensification of Biotherapeutics