Principal Scientist (Bioanalytics)

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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.