Descripción
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 interactio...