Senior Bioanalytical Scientist: mRNA-LNP & Potency Assays

Lonza; Netherlands; Remote; Confidential; Full time

Job summary

Lonza in The Netherlands seeks a senior Analytical Development specialist to develop and run dedicated (bio)analytical methods, support product development and quality control, and supervise new team members.

You will plan and document pre-validation studies, author SOPs, train colleagues, and act as SME in interactions with internal and external stakeholders. A Master or PhD with experience in RNA-LNP bioassays and flow cytometry is required.

Qualifications

• Master or PhD with years of analytical development experience.
• 3 years experience in analytical development of Bioassays in mRNA-LNP area.
• Experience in analytical method development and validation per ICH/USP guidelines.
• Strong focus on potency assays and RNA-LNP bioassays.
• Experience with cellular work and aseptic handling.

Responsibilities

• Transfer, optimize, and develop bioanalytical methods for product development and QC.
• Plan, execute, and document pre-validation studies per regulatory requirements.
• Author SOPs and ensure GMP-aligned documentation.
• Train colleagues and transfer validated methods to QC.
• Perform routine testing for development campaigns and stability studies.
• Represent the Analytical Development department as SME in interactions with stakeholders.

Skills

Analytical development

mRNA-LNP bioassays

Flow cytometry

ELISA

Statistical methods

Cell culture

Staff leadership

Project management

Regulatory compliance

Education

Master's degree

PhD

Tools

Sanger sequencing

Oxford Nanopore sequencing

qPCR

LC-MS

Job description

Lonza in The Netherlands seeks a senior Analytical Development specialist to develop and run dedicated (bio)analytical methods, support product development and quality control, and supervise new team members.

You will plan and document pre-validation studies, author SOPs, train colleagues, and act as SME in interactions with internal and external stakeholders. A Master or PhD with experience in RNA-LNP bioassays and flow cytometry is required.