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.