p(Associate) Principal Scientist Bioanalytics /ppLonza /ppBasel, Switzerland /ph3What you will do: /h3pResponsible for leading and managing pharmaceutical development projects of drug entities within Development Bioanalytics (DevBA) from various customers and in different pre-clinical development phases. /ppAccountable for the successful delivery of work packages for assigned projects. This includes on-time close out/authorization and provision of required analytical testing results, documents and reports (e.g. establishment and pre-validation, non-GMP batch release and stability studies), leading investigation in compliance with ISO standards. /ppAccountable to independently and proactively address risks and resolve issues of deliverables on time for mitigation, including good communication to all stakeholders potentially affected. /ppRepresents DevBA in Lonza internal project meetings and customer meetings for complex topics as SME (Subject Matter Expert). /ppSupports the relevant stakeholder (e.g. APL) to maintain all relevant planning tools. /ph3What we are looking for: /h3pA PhD degree in Biochemistry, Biotechnology, Analytical Science, or related Life Sciences field, or equivalent relevant experience, is required. /ppExperience working within the Bio-Pharmaceutical industry as a research or technical expert preferably using potency assays for various modalities (Monoclonal Antibodies, Bi/trispecific Antibodies, Enzymes, Peptides, recombinant proteins, ADCs, etc…). /ppStrong expertise in the set-up, optimization, transfer, and troubleshooting of cell-based assays (CBA), as well as broad knowledge of analytical techniques including mammalian cell culture and ligand-binding assays such as ELISA, enzyme assay and SPR. /ppGood knowledge in guidelines for analytical methods (ICH Q14/ICH Q2). /ppExcellent communication skills, team player, flexibility and ability to manage complexity. /ppFluent in English is a must. Any other languages are a plus. /p #J-18808-Ljbffr
