Principal Scientist Bioanalytics

Principal Scientist Bioanalytics

Lonza

Geleen, Netherlands

€ 60.750 - € 85.050 per year

As a member of the Analytical Development Team, you will be in charge of developing and running dedicated (Bio)analytical methods, while assisting with other ongoing developments, based on customer needs. You are responsible to ensure analytical development is in line with quality control. You are accountable for the performance and results of the assigned projects. Thereby you support and supervise new members of the group.

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:

• PhD + multiple years of experience in analytical development
• Expertise in analytical development of Bioassays in the area of mRNA-LNP.
• 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.