Principal Scientist (Bioanalytics)

Principal Scientist (Bioanalytics)
Lonza
Geleen, Netherlands
What you will do:
Transfer, optimize, and develop bioanalytical methods to support product development and quality control;
Plan, execute, and document method pre-validation studies in accordance with applicable regulatory requirements;
Authoring of Standard Operating Procedures (SOPs);
Technical support in cross departmental documentation (validation documents, development documents);
Train colleagues and transfer pre-validated methods to the GMP-compliant Quality Control (QC) department;
Perform routine testing for development campaigns and stability studies as required;
Represent the Analytical Development department as a Subject Matter Expert (SME) in interactions with internal stakeholders and external clients;
Represent the Analytical Development department as a Subject Matter Expert (SME) and/or Project Team Member (PTM) in interactions with internal stakeholders and external clients.
What we are looking for:
Master or PhD + multiple years of experience in analytical development;
3 years experience in analytical development of Bioassays in the area of mRNA-LNP in pharmaceutical industry;
Practical and theoretical experience in analytical method development and validation, with a strong focus on potency assays in accordance with ICH and USP guidelines in the field of RNA-LNP bioassays. Especially regarding Flow Cytometry (FACS) and ELISA;
Deep understanding of statistical methods relevant to analytical method development and validation;
Practical experience with cellular work (aseptic handling);
Ability to lead junior staff and further their development;
Be a collaborative team player with a flexible and proactive mindset who thrives in a dynamic environment and views changing priorities as opportunities;
Curiosity and enthusiasm for implementing and evaluating new analytical technologies;
Very good communication skills and interaction with project organization and customers.
Preferred:
Initial experience with GMP-compliant documentation and laboratory practices;
Hands-on and deep theoretical experience with at least two of the following analytical techniques including trouble shooting: Sanger Sequencing, Oxford Nanopore Technology Sequencing, Quantitative PCR (qPCR), Liquid Chromatography coupled with Mass Spectrometry;
Initial experience in project management and/or customer management within an analytical development environment.
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